Pooja Singhal, MD, is a gastroenterologist, hepatologist, and obesity medicine specialist at Oklahoma Gastro Health and Wellness.

Pooja Singhal, MD | Image Credit: Oklahoma Gastro Health and Wellness

 published a Commission establishing an official definition and diagnostic criteria for 

, aiming to alter the way the condition is approached in 

The central conceit of the Commission was the difference between clinical and preclinical obesity, which is described as the presence or absence of objective clinical manifestations. These primarily include altered organ function or the impairment of a patient’s ability to conduct daily activities. A lens this specific allows clinicians to account for patients who are technically obese but exhibit no comorbidities, outwardly appearing to be in good health.

Additionally, the Commission provided suggestions for altering the diagnostic process for obesity, encouraging the abandonment of the body mass index (BMI) as the sole indicator. Instead, the commissioners suggest the utilization of ≥2 individual anthropometric criteria, such as waist circumference, or direct fat measurement when possible. This should prevent the rampant overdiagnosis of obesity that was predicted by the Commission.

To address how the Commission’s decision has influenced endocrinology since its publication, the editorial team at 

 spoke with Pooja Singhal, MD, a gastroenterologist, hepatologist, and obesity medicine specialist at Oklahoma Gastro Health and Wellness, in the following Q&A:

: How has the move toward formally defining obesity as a disease shaped the landscape of obesity care?

: I think defining obesity as a disease was truly transformational. It helped establish a scientific and moral basis for treating obesity directly. You know, in the past, we used to treat the complications – sleep apnea, diabetes, hypertension, cardiovascular disease, MASLD. Now it has helped us to have a newer approach, which is that obesity itself is a disease, and we need to treat that and prevent complications. I think this reframing has been revolutionary and has really redefined how we approach obesity in general. It’s validated that obesity should be treated. It is a disease, and it should be treated before complications arise. It also helped reduce this kind of moral blame on patients by defining it as a true disease that exists on its own, in its own right. It has promoted earlier intervention proactiveness to seek help, and I also think it’s going to help and already has helped early intervention in pediatric obesity, because that’s what we have seen more and more of. I think the whole Commission’s work is helping us in all these ways.

: To what extent has defining obesity as a disease opened the door to broader acceptance of pharmacologic treatment, especially GLP-1s?

: I think GLP-1s have fit perfectly into this new narrative of biological disease. Because it’s really when people see results, when they see that a medication that works neurohormonally can lead to appetite curbing and lead to the weight loss that people were absolutely not able to achieve, no matter what they tried. It has changed that narrative and acceptance as a community, as a society, even globally, that obesity is truly a disease and regulation of appetite signaling has a big role in it. So, I think the timing of the GLP-1s and the results have also been very much a boon to this biologic narrative of obesity as a disease without that disease framing, where GLP-1s would not have been culturally accepted.

: What other details can you provide around clinicians’ views of obesity following the Commission?

: It’s also led to the clinician’s view of obesity has changed too. Before, it was kind of episodic treatment, if you will. Now there’s more willingness to view pharmacotherapy as a first-line option of obesity for many patients. In the past, it was all about diet and exercise and lifestyle changes. Now, more and more clinicians understand that obesity is a disease, and early prevention and treatment could lead to preventing some very serious complications. So I do also love the fact that it has informed clinician behavior as well and promoted chronic management approach rather than episodic weight loss attempts.

Rubino F, Cummings DE, Eckel RH, et al. Definition and diagnostic criteria of clinical obesity. 

Livingston R. The Lancet Commission on Obesity: Redefining Endocrinology’s Most Notorious Condition. 

. December 18, 2025. Accessed December 19, 2025. 

https://www.hcplive.com/view/the-lancet-commission-on-obesity-redefining-endocrinology-s-most-notorious-condition

Articles

The Lancet Diabetes & Endocrinology Commission has redefined obesity by distinguishing between clinical and preclinical obesity, focusing on objective clinical manifestations. This new definition encourages moving beyond BMI as the sole diagnostic tool, advocating for multiple anthropometric criteria. The reclassification of obesity as a disease has transformed its treatment, promoting early intervention and reducing patient stigma. It has also facilitated the acceptance of pharmacologic treatments like GLP-1s, shifting clinician perspectives towards chronic management rather than episodic interventions.

Singhal discusses the multi-pronged impact of the Commission’s definition of obesity and how it effects clinicians, patients, and the treatment structure itself.

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Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Impacts of the Lancet Commission on Obesity Treatment, With Pooja Singhal, MD

Hanny Al-Samkari, MD, is the Peggy S. Blitz Endowed Chair in hematology and oncology at the Massachusetts General Hospital and an associate professor of medicine at Harvard Medical School.

Systemic Bevacizumab Improves Chronic Bleeding from GI Lesions, With Hanny Al-Samkari, MD

Systemic bevacizumab has proven its safety and efficacy in treating 

 from gastrointestinal (GI) vascular lesions across a variety of non-hereditary hemorrhagic telangiectasia (HHT) etiologies – including idiopathic angiodysplasia, esophageal varices, and von Willebrand disease – among adult and elderly patients, according to data from a recent observational study.

Previous case studies have investigated systemic bevacizumab for various forms of GI bleeding. A patient with HHT and a massive transfusion dependence saw drastic improvement in required red blood cell (RBC) transfusions after 12 months of treatment with bevacizumab. Another patient, a 69-year-old man with severe 

 as a result of small bowel angioectasia bleeding, demonstrated improved hemoglobin levels after several months of bevacizumab treatment.

67th American Society of Hematology (ASH) Annual Meeting and Exposition

 in Orlando, Florida, by Hanny Al-Samkari, MD, the Peggy S. Blitz Endowed Chair in hematology and oncology at the Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, these data may provide a more efficient and longer-lasting method of treating severe chronic bleeding compared to surgical interventions.

“Right now, the standard of care is to go in and do local ablation with argon plasma, coagulation, clipping, and things like this to the lesions,” Al-Samkari told 

. “But all these conditions have an underlying angiogenic dysregulation such that there’s excessive angiogenic signal. And the more tissue injury you do, the more lesions you provoke to grow. You go in, you cauterize, you do whatever you can, but then a few months later, the bleeding is back, and often worse than before.”

Al-Samkari and colleagues conducted an observational study of patients with non-HHT severe chronic bleeding from GI vascular lesions of any etiology refractory to standard therapies, who had been treated with off-label systemic bevacizumab. The primary endpoint was hematologic support requirements, such as RBC transfusions and intravenous (IV) iron infusions, measured in RBC unit equivalents (1 RBC unit equivalent = 1 RBC unit or 250 mg IV elemental iron). Secondary endpoints included hemoglobin, IV iron, and RBC transfusions measured independently, as well as safety.

A total of 23 patients with chronic, severe bleeding received bevacizumab. The median age was 78 years (range, 42-90), and all but 1 patient was ≥60 years. All patients began treatment at 5 mg/kg daily (77%) or 2.5 mm/kg daily (23%) and were infused every 2 weeks for 4 treatments, followed by 2.5-5 mg/kg daily every 4 weeks. Treatment lasted for up to 4.2 years.

Ultimately, hematologic support required substantially improved from 6 months pretreatment (median 14.2 RBC unit equivalents [interquartile range [IQR] 10-23.9]) during months 1-6 (4.1 [2-7.1] RBC unit equivalents; 

 = .0003) and further improved during months 7-12 (0.6 [0-3.5] RBC unit equivalents; 

 >.001). These improvements coincided with improvements in median (IQR) hemoglobin, measured at 8.2 (7.7-9.4) g/dL at baseline, 10.1 (8.6-12.9) g/dL at month 3, 12.2 (9.6-13) g/dL at month 6, 10.6 (8.8-13.1) g/dL at month 9, and 10.4 (8.9-13.3) g/dL at month 12 of bevacizumab treatment (

Additionally, patients in the cohort required 60 emergency department visits or hospital admissions specifically for GI vascular lesion bleeding in the 12 months prior to initiation, compared to 21 in the 12 months after the initiation. The median number of visits and admissions per patient improved from 3.5 (IQR, 1-5) to 1 (0-1.25) (

 – .0049). Proteinuria was the most common treatment-emergent adverse event (TEAE), occurring in 7 patients (30%), followed by hypertension in 6 (26%) and fatigue in 3 (13%). No venous or arterial thromboembolic events occurred, and no fatal TEAEs were noted. Ultimately, 3 patients discontinued for TEAEs, all of which were grade 3 proteinuria, and 5 discontinued for inadequate treatment effect.

“Not only did bevacizumab trigger a dramatic improvement in Hematologic Support Score, it reduced hospitalizations and emergency department visits, specifically due to vascular GI bleeding in these patients, by >50% in the year after versus the year before starting bevacizumab,” Al-Samkari said. “And it did it pretty safely; most patients were able to deal with the side effects and stay out of the hospital with monthly to every 2-month low-dose bevacizumab infusions.”

Editor’s Note: Al-Samkari reports disclosures with Pharmacosmos, Agios, Amgen, Vaderis, Novartis, Sobi, and others.

Ayad N, Al-Samkari H. Long-term safety and effectiveness of systemic bevacizumab for chronic severe bleeding in idiopathic gastrointestinal angiodysplasia, esophageal varices, and angiodysplasia of von Willebrand disease and acquired von Willebrand syndrome. Abstract presented at the 67th American Society of Hematology Annual Meeting. Orlando, FL. December 6-9, 2025.

Ou G, Galorport C, Enns R. Bevacizumab and gastrointestinal bleeding in hereditary hemorrhagic telangiectasia. World J Gastrointest Surg. 2016;8(12):792-795. 

Compare D, Sgamato C, Rocco A, et al. Long-term bevacizumab is safe and effective in managing small bowel angioectasias bleeding refractory to conventional treatments: a case report. Gastroenterol Rep (Oxf). 2024;12:goae070. Published 2024 Jul 6. 

Videos

Al-Samkari discusses a potentially novel use for bevacizumab in improving outcomes for patients with lesions from non-HHT etiologies.

Hematology

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Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A new study reported that kinesiophobia and central sensitization frequently occur in patients with 

 and were linked to increased pain intensity and decreased quality of life, mental health, functionality, and physical activity.

Kinesiophobia, defined as an excessive fear of physical movement often following a traumatic injury, can significantly impair patients’ quality of life.

 Efforts to avoid movement to prevent pain may paradoxically lead to worsening pain. Kinesiophobia leads to a loss of physical mobility, physical fitness, inactivity, functional decline, and psychological issues with the belief that movement will increase pain. Research has shown that kinesiophobia has contributed to increased levels of disability and pain intensity.

A study published in January 2025 reported that 48.3% of 424 patients with a musculoskeletal disorder had kinesiophobia (95% confidence interval [CI], 43.3 to 53.3).

 Factors included being overweight or obese (adjusted odds ratio [aOR], 3.98), having a moderate pain level (aOR, 3.31), having a severe pain level (aOR, 9.29), physical inactivity (aOR, 3.00), anxiety (aOR, 2.57), and depression (aOR, 8.21).

Another study published in February 2025 identified the prevalence of kinesiophobia in patients with chronic diseases between 42.85% to 93%, depending on the condition.

 However, this study did not include participants with gout, instead focusing on cardiovascular diseases, cancers, diabetes, and chronic respiratory diseases.

In this recent cross-sectional analysis, Kübra Tuncer, from the department of physical medicine and rehabilitation at Cukurova University in Türkiye, and colleagues sought to assess the prevalence of kinesiophobia and central sensitization among patients with gout and age- and gender-matched controls. The team also assessed the association between these factors and clinical gout outcomes.

Investigators assessed kinesiophobia and central sensitization in patients using the Tampa Scale of Kinesiophobia (TSK) and Central Sensitization Inventory (CSI), respectively. They measured clinical outcomes via the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Gout Activity Score (GAS), and Health Assessment Questionnaire-Disability Index (HAQ-DI).

The study reported a 62.3% and 33.8% prevalence of kinesiophobia and central sensitization in patients with gout, respectively. Patients with gout had greater scores for Tampa Scale of Kinesiophobia, Central Sensitization Inventory, and Hospital Anxiety and Depression Scale compared to controls, but lower scores of SF-36 and International Physical Activity Questionnaire-Short Form.

Moreover, patients with kinesiophobia displayed statistically greater scores of Gout Activity Score, Central Sensitization Inventory, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability Index. These individuals also had lower sub-scores of SF-36, excluding the emotional role, and total International Physical Activity Questionnaire-Short Form scores than those without kinesiophobia.

Additionally, patients with central sensitization had greater scores in the Gout Activity Score, Tampa Scale of Kinesiophobia, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability, as well as lower scores in the SF-36 and total International Physical Activity Questionnaire-Short Form.

The analysis revealed that scores in the Tampa Scale of Kinesiophobia and Central Sensitization Inventory had significant positive correlations with each other and with pain, Gout Activity Score, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability Index. The regression analyses showed that the Central Sensitization Inventory score appeared to determine kinesiophobia severity.

Overall, this study suggests that mental health plays a large role in influencing central sensitization in gout. The research showed that central sensitization was independently associated with kinesiophobia.

“These close associations lead to challenges in optimizing management, functionality, physical activity level, and quality of life in gout,” investigators wrote.

Tuncer K, Kozanoğlu E, Sariyildiz A, Yetişir A. Evaluation of kinesiophobia, central sensitization, and related factors in patients with gout: a cross-sectional study. 

Mekonnen Y, Gashaw M, Abich Y, Takele MD, Chanie ST, Wayessa DI, Deme S, Kibret AK. Kinesiophobia and associated factors among people with musculoskeletal disorders in Ethiopia: a multicenter cross-sectional study. BMC Musculoskelet Disord. 2025 Jan 15;26(1):55. 

doi: 10.1186/s12891-025-08306-7. PMID: 39815219; PMCID: PMC11734341.

Wlazło M, Szlacheta P, Grajek M, Staśkiewicz-Bartecka W, Rozmiarek M, Malchrowicz-Mośko E, Korzonek-Szlacheta I. The Impact of Kinesiophobia on Physical Activity and Quality of Life in Patients with Chronic Diseases: A Systematic Literature Review. 

Kinesiophobia and central sensitization are prevalent in gout patients, significantly impacting pain intensity, quality of life, mental health, and physical activity. A recent study found 62.3% of gout patients experienced kinesiophobia, while 33.8% had central sensitization. These conditions were linked to higher scores on the Gout Activity Score, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability Index. The study highlighted the strong correlation between kinesiophobia and central sensitization, emphasizing the role of mental health in managing these conditions and their impact on gout management.

Patients with gout frequently experience kinesiophobia and central sensitization, which were independently linked to greater pain intensity.

Gout

On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

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Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Fear of Movement, Central Sensitization May Worsen Outcomes in Gout

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Altimmune has announced positive topline results from the phase 2b IMPACT trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks.

As described in a December 19, 2025, press release from the Company, topline 48-week data showed treatment with pemvidutide achieved statistically significant improvements across treatment arms in key noninvasive tests (NITs), including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), versus placebo. Of note, these data exhibited continued reductions from week 24 and provide evidence of continued improvement in antifibrotic activity with both treatment doses.

“The magnitude of response versus placebo on measures such as ELF and LSM at 48 weeks makes these data particularly compelling, as these noninvasive markers have been shown to correlate with histologic fibrosis stage. These results reinforce that pemvidutide may address both liver-specific and metabolic drivers of MASH without compromising tolerability – three critical elements of a potential effective treatment for this patient population,” Mazen Noureddin, MD, IMPACT trial principal investigator, professor of medicine at Houston Methodist Hospital and co-chairman of the Board for Summit and Pinnacle Clinical Research, said in a statement.

 “I am encouraged by the dose response observed and the performance of the 1.8 mg arm and I am eager to see this differentiated therapeutic candidate advance into Phase 3 evaluation.”

Additionally, Altimmune announced that it held a productive End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) resulting in alignment on the parameters for a registrational phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis.

Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of MASH, alcohol use disorder (AUD) and alcohol-associated liver disease (ALD).

The randomized, placebo-controlled, double-blind IMPACT trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomly assigned in a 1:2:2 ratio to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks.

The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks.

Results showed pemvidutide-treated participants achieved statistically significant reductions in primary non-invasive markers of fibrosis, including ELF and LSM:

ELF: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -0.49 and -0.58 respectively, versus +0.16 in placebo-treated patients (

LSM: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -3.04 (

<.001), respectively, versus -0.03 in placebo-treated participants

The proportion of participants receiving pemvidutide 1.2 mg and 1.8 mg who achieved both a ≥0.5 reduction in ELF and a 30% reduction in LSM were 27.8% (

<.0001) respectively, versus 3.2% in placebo-treated participants.

Further analysis revealed participants who received the pemvidutide 1.2 mg and 1.8 mg doses achieved a mean reduction in liver fat content from baseline of 45.2% and 54.7% respectively, compared to 8.2% in participants who received placebo (

<.0001). For ALT, 1.2 mg and 1.8 mg achieved a mean reduction from baseline of -37.8 IU/L and -37.4 IU/L respectively, versus -10.3 IU/L in placebo-treated participants (

<.0001, both doses). For cT1, 1.2 mg and 1.8 mg achieved a mean reduction from baseline of -124 and -140 milliseconds respectively, versus -21 milliseconds in placebo-treated participants (

Results additionally showed participants receiving pemvidutide 1.2 mg and 1.8 mg achieved weight loss of 4.5% and 7.5%, respectively, compared with 0.2% of placebo-treated participants (

<.0001, both doses). Of note, no plateauing at 48 weeks was observed with the 1.8 mg dose.

Adverse events leading to treatment discontinuation occurred in 0% and 1.2% of patients treated with pemvidutide 1.2 mg and 1.8 mg, respectively, versus 3.5% of participants on placebo. Investigators noted no serious or severe adverse events related to treatment were reported.

Altimmune and the FDA have aligned on the parameters for a registrational phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis. With the FDA’s recent qualification of AIM-MASH AI Assist, the Agency was open to the Company’s intent to integrate use of this AI tool into the phase 3 trial.

“With the benefit of FDA feedback and these 48-week data now in hand, we are greatly looking forward to progressing pemvidutide to a Phase 3 program which we intend to initiate in 2026. Strong evidence of antifibrotic improvements based upon non-invasive tests, combined with an attractive tolerability profile, highlight pemvidutide’s differentiation and potential to be a meaningful treatment option for the MASH patient community,” said Vipin Garg, PhD, Chief Executive Officer of Altimmune.

Altimmune. Altimmune Announces that Pemvidutide Achieved Key Measures of Success at 48 Weeks in IMPACT Phase 2b MASH Trial. December 19, 2025. Accessed December 19, 2025. 

https://www.globenewswire.com/news-release/2025/12/19/3208385/0/en/Altimmune-Announces-that-Pemvidutide-Achieved-Key-Measures-of-Success-at-48-Weeks-in-IMPACT-Phase-2b-MASH-Trial.html

US Food and Drug Administration. FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials. December 8, 2025. Accessed December 19, 2025. 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-qualifies-first-ai-drug-development-tool-will-be-used-mash-clinical-trials

Altimmune's phase 2b IMPACT trial of pemvidutide, a glucagon/GLP-1 dual receptor agonist, demonstrated significant improvements in metabolic dysfunction-associated steatohepatitis (MASH) patients over 48 weeks. The trial showed statistically significant reductions in non-invasive fibrosis markers, liver fat content, and weight loss compared to placebo. The trial's success led to alignment with the FDA on a phase 3 trial, incorporating AI tools. Pemvidutide's favorable tolerability and efficacy profile suggest its potential as a promising treatment for MASH, with phase 3 trials planned for 2026.

Positive topline results from the phase 2b IMPACT trial show statistically significant improvements in key noninvasive tests with pemvidutide.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Pemvidutide Shows Continued Antifibrotic Activity for MASH, Progresses to Phase 3 Trial

The US Food and Drug Administration has approved Grifols’ fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia.

According to a December 19, 2025, press release from the Company, fibrinogen, human-chmt will be commercialized in the US by Grifols and is expected to be available during the first half of 2026.

“With the approval of [fibrinogen, human-chmt], we are excited to be able to provide U.S. health care providers and patients with CFD a safe, effective and reliable treatment for acute bleeding episodes – when every minute counts,” Roland Wandeler, President of Grifols Biopharma, said in a statement.

 “This is another meaningful step forward in our mission to bring more medicines to more patients around the world.”

CFD is a rare inherited condition present from birth and caused by genetic mutations affecting the production or function of fibrinogen. Produced in the liver, fibrinogen is a plasma protein essential for blood clotting and wound healing. Without sufficient fibrinogen levels, the body cannot effectively control bleeding, particularly during acute bleeding events.

Treatment options for low fibrinogen levels include fresh frozen plasma, cryoprecipitate or fibrinogen concentrate. Cryoprecipitate and fresh frozen plasma include additional proteins and components that are not necessary for fibrinogen replacement and often require infusions of large volumes to achieve adequate fibrinogen levels.

Fibrinogen, human-chmt is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. It is manufactured at the “Biotest Next Level” production facility in Dreieich, Germany. The US is the second country to approve this new fibrinogen concentrate, the first being Germany in November, where it is commercialized by Biotest under the brand Prufibry. Approvals in additional European markets are expected in 2026.

Its approval in the US was based on evidence from the clinical study “A Prospective, Open-label, Phase I/III Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen Deficiency.”

The most serious adverse reactions observed with fibrinogen, human-chmt were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of fibrinogen, human-chmt.

In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving fibrinogen, human-chmt were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.

As described in the press release, Grifols expects the product to be available during the first half of 2026.

Grifols. Grifols receives US FDA approval for new fibrinogen concentrate, FESILTYTM (fibrinogen, human-chmt). December 19, 2025. Accessed December 19, 2025. 

https://www.grifols.com/en/view-news/-/news/grifols-receives-us-fda-approval-for-new-fibrinogen-concentrate-fesiltytm-fibrinogen-human-chmt

Grifols. Grifols’ Biotest receives first regulatory approval for its fibrinogen concentrate. November 13, 2025. Accessed December 19, 2025. 

https://www.grifols.com/en/view-news/-/news/grifols-biotest-receives-first-regulatory-approval-for-its-fibrinogen-concentrate

The US FDA has approved Grifols' fibrinogen, human-chmt (Fesilty) for treating acute bleeding in patients with congenital fibrinogen deficiency (CFD). This condition, caused by genetic mutations, impairs fibrinogen production, crucial for blood clotting. Traditional treatments like fresh frozen plasma and cryoprecipitate are less efficient due to additional proteins. Fibrinogen, human-chmt, already approved in Germany, will be available in the US by mid-2026. Clinical trials showed efficacy but noted serious adverse reactions, including thrombotic events. Grifols aims to expand its availability in Europe by 2026.

Grifols’ fibrinogen concentrate is now approved for acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency.

FDA News

FDA Approves Fibrinogen, Human-chmt (Fesilty) for Congenital Fibrinogen Deficiency

The panel discusses the importance of monitoring and supporting vitamin status in patients receiving ATTR-CM therapies, particularly those on transthyretin silencers that reduce hepatic production of TTR. Because TTR transports retinol-binding protein, lowering TTR levels can affect vitamin A transport. The clinicians explain that when silencing therapy is used, patients should receive vitamin A supplementation, but at the appropriate physiologic dose, not excess replacement. They caution that high-dose vitamin A can be harmful and stress the need to avoid overcorrection, particularly in older adults.
The panel also notes that education is essential, as patients may assume all supplements are beneficial or may take additional over-the-counter vitamins without disclosing them. Clear counseling helps ensure patients understand what to take, what to avoid, and why. Overall, the discussion emphasizes thoughtful, monitored supplementation as part of comprehensive care, rather than a standalone intervention.


Video Series

The Role of Vitamin Supplementation in Patients Receiving ATTR-CM Therapies

In this episode, the panelists focus on evaluating the safety profile of IL-17 inhibitors in psoriatic disease. The experts explain that IL-17 therapies are generally well tolerated and offer a favorable safety profile compared with older systemic agents like TNF inhibitors and methotrexate, which require frequent lab monitoring. They note that while all IL-17 inhibitors share certain class effects, the most commonly observed adverse event is mucosal or oral candidiasis, which is typically mild, manageable, and tends to decrease over time. The panelists emphasize careful patient selection, avoiding IL-17 inhibitors in individuals with a history of inflammatory bowel disease (IBD), given the risk of exacerbation. They briefly discuss safety observations from dual IL-17A and IL-17F blockade, noting reports of liver enzyme elevation and mood changes, though these lack strong mechanistic evidence. Overall, the experts conclude that IL-17 inhibitors provide a safe, targeted, and effective option for long-term psoriasis and PsA management.

Evaluating the Safety Profile of IL-17 Inhibitors in Psoriatic Disease

Panelists discuss the questions below in this video. 
ESK-001, another highly selective TYK2 inhibitor, has advanced into phase 3 trials in plaque psoriasis. How does its mechanism of action and emerging phase 2 data compare with deucravacitinib and zasocitinib, and what features might distinguish it within the TYK2 inhibitor class?

Other Emerging TYK2 Inhibitors in Psoriasis

Panelists discuss the questions below in this video. 
How do you see emerging TYK2 inhibitors, such as zasocitinib and ESK-001, fitting into the psoriasis treatment landscape, if approved? Building on IMMpulse findings that earlier biologic use in moderate psoriasis can improve outcomes, what opportunities do you see for TYK2 inhibitors to be used earlier in appropriate patients? 

Opportunities for TYK2 Inhibition in Moderate Psoriasis

The panel discusses the role of transthyretin (TTR) stabilizers in the management of ATTR-CM, focusing on tafamidis and acoramidis. They explain that both agents work by stabilizing the TTR tetramer to prevent dissociation and subsequent amyloid fibril formation. Tafamidis is highlighted as the first approved stabilizer with demonstrated benefit in reducing morbidity and mortality in ATTR-CM. Clinicians note that many patients experience stable disease over time with tafamidis, and its favorable tolerability profile, with minimal need for laboratory monitoring, is especially helpful for older adults seeking consistent, manageable treatment.
The discussion then shifts to acoramidis, which is designed to strongly stabilize the TTR protein. The panel describes clinical impressions that acoramidis has shown promising results in trials and represents an important emerging option. They emphasize that having multiple stabilizers broadens therapeutic choice and may help align treatment selection with patient needs and disease characteristics, reinforcing the importance of earlier diagnosis and appropriate therapy initiation.


Efficacy and Safety of Transthyretin Stabilizers in ATTR-CM

In this episode, the panelists discuss long-term IL-17 data and real-world evidence on preventing psoriatic arthritis (PsA) in patients with psoriasis. They highlight results from the five-year secukinumab study presented at ACR Convergence 2025, which showed that 97.9% of psoriasis patients treated with secukinumab did not develop PsA over the study period. The experts view this as compelling evidence supporting the disease-modifying potential of IL-17 inhibition. They also reference real-world data which compared PsA incidence across biologic classes and found that IL-17 and IL-23 inhibitors were associated with a lower PsA risk than TNF inhibitors or methotrexate. The panelists emphasize that IL-17 inhibitors not only achieve durable skin clearance but also offer a favorable safety profile and reduced need for lab monitoring. Overall, they interpret these findings as reinforcing the role of targeted IL-17 blockade in preventing PsA progression in high-risk psoriasis patients.

Long-Term IL-17 Data and Real-World Comparisons: Preventing PsA in Psoriasis

New research shows both left and bilateral taVNS are safe, noninvasive treatment options that relieve pain in individuals with fibromyalgia.


Fibromyalgia

On the HCPLive fibromyalgia page, resources on the topics of medical news and expert insight into fibrositis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on fibromyalgia, and more.

 taVNS Reduces Pain, Improves Mood in Fibromyalgia Patients

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Topline results show GLPG3667 met its primary endpoint in a phase 3-enabling dermatomyositis trial but missed in systemic lupus erythematosus.


Lupus

GLPG3667 Meets Primary Endpoint in Dermatomyositis, Misses in SLE Phase 3 Trials

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

In a new post hoc analysis of 4 pivotal clinical studies in atopic dermatitis and prurigo nodularis, nemolizumab was shown to improve symptoms.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Nemolizumab Rapidly Relieves Itch in Atopic Dermatitis, Prurigo Nodularis

Topical steroid withdrawal remains a controversial topic in the dermatology field, given the lack of necessary data. 

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

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