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 small prospective, double-blind study found that heated cow’s milk desensitization did not provide clear immunologic advantages over conventional raw milk oral immunotherapy in children with IgE-mediated 

 and was associated with more frequent anaphylaxis.

“According to our findings, the serum level of IgE decreased significantly after desensitization in both groups, but no statistically significant difference was observed between these two methods in terms of reducing IgE antibody levels,” wrote study investigator Masoud Movahedi, from Children’s Medical Hospital at Tehran University of Medical Sciences in Iran, and colleagues.

Cow’s milk allergy is among the most common immunoglobulin E (IgE)–mediated food allergies in pediatric populations. In several countries, prospective studies have reported that cow’s milk triggers an allergic reaction in 2.5% of infants during the first year of their life.

 Most infants with non–non-IgE-mediated reactions to cow’s milk outgrow the allergy by age 3; however, 10% to 25% of those with IgE-mediated milk allergy will continue to have the condition a decade later.

The only accepted treatment for cow’s milk allergy is avoidance and treating acute reactions. However, avoiding cow’s milk entirely may have consequences. The dietary restriction can lead to growth disorders and a lack of macronutrients and micronutrients.

Immunotherapy and desensitization can help children safely tolerate cow’s milk. Heating milk alters protein structures and chemical interactions, reducing the exposure of allergenic sites to the immune system. This modification of spatial epitopes prevents recognition by immune cells and decreases the risk of an allergic reaction. However, how effective is desensitization using heated milk versus the usual method of oral desensitization?

In this study, the team sought to assess the immunological changes following the consumption of heated cow’s milk products compared to the usual method of oral desensitization in 25 children > 2 years old with cow’s milk allergy.

 Children were included in the study if they had a reaction within ≤ 2 hours after consuming cow’s milk during the past 6 months, such as urticarial, erythema, angioedema, acute vomiting, abdominal pain, diarrhea, rhinitis, and bronchospasm, within ≤ 2 hours after consuming cow’s milk during the past 6 months. Children also had a positive food challenge test, a positive skin test, or a positive serum-specific IgE test to cow’s milk. They were all referred to the allergy clinic at the Children’s Medical Center from 2016 to 2017.

Investigators randomized children to 2 arms: desensitization with heated cow’s milk (intervention treatment; n = 12; mean age, 4.50 ± 1.73 years) and desensitization with raw milk (normal treatment; n = 13; mean age, 3.92 ± 1.44 years). The anaphylaxis rate was greater in the heated milk group vs the raw milk group (50% vs 15.4%). The two treatments had no significant difference in the incidence of urticaria and angioedema.

The mean concentration of serum IgE decreased in both groups after desensitization, with no significant difference between heated versus raw milk (

 =.028). The raw milk group had more of an increase in CD4+Foxp3+ and CD4+CD25+ cells compared with the heated milk group, but this finding was nonsignificant (

=.058, respectively). Similarly, investigators observed a greater number of eosinophil cells in the heated milk group versus the raw milk group, but the difference was not statistically significant (

“We conclude that the immunological changes induced by a diet containing heated milk were not significantly different from those observed with conventional oral desensitization,” investigators wrote.

 “Further, it is recommended that multicenter studies with larger sample sizes be conducted to investigate the number and function of mast cells and basophils, as well as the phenotype of TH1 and TH2 cells.”

Movahedi M, Bahraminia E, Amirzargar A. Comparison of Oral Desensitization with Heated Cow's Milk Products with Conventional Desensitization Method in Children with Cow's Milk Allergy. 

. 2025;24(6):734-740. Published 2025 Oct 29. 

Milk Allergy. Food Allergy Research & Education. Accessed December 19, 2025. 

https://www.foodallergy.org/living-food-allergy/food-allergy-essentials/common-allergens/milk

Articles

A small prospective, double-blind study compared heated cow’s milk desensitization to conventional raw milk oral immunotherapy in children with IgE-mediated cow’s milk allergy. Both methods showed a significant decrease in serum IgE levels, but no significant difference between them. The heated milk group experienced a higher rate of anaphylaxis compared to the raw milk group. The study found no significant differences in immunological changes between the two methods. Researchers recommend larger multicenter studies to further investigate the immunological effects and safety of these desensitization methods.

Study finds comparable IgE reductions with heated milk and conventional desensitization, but heated milk linked to higher anaphylaxis risk in children with cow’s milk allergy.

News

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clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

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Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Heated Milk Desensitization Offers No Clear Advantage Over Raw Milk in Children

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration approvals of lerodalcibep-liga (Lerochol) injection for adults with hypercholesterolemia, depemokimab-ulaa (Exdensur) as an add-on maintenance treatment for severe asthma, and fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, as well as Breakthrough Device Designation granted to to the Holly™ implantable, continuous dialysis system and positive topline results from a pair of phase 3 studies of zasocitinib in adults with moderate-to-severe plaque psoriasis (PsO).

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of December 14, 2025—let’s jump in!

FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

On December 15, 2025, the FDA approved LIB Therapeutics’ lerodalcibep-liga (Lerochol) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

The novel, third-generation PCSK9 inhibitor is self-administered as a once-monthly, single small-volume subcutaneous injection with extended room-temperature stability up to 3 months.

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

On December 17, 2025, the FDA approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age. The decision was based on data from the phase 3 SWIFT-1 and SWIFT-2 trials showing sustained exacerbation reduction with 2 doses per year versus placebo, both plus standard of care.

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

On December 19, 2025, the FDA approved Grifols’ fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. The product will be commercialized in the US by Grifols and is expected to be available during the first half of 2026.

FDA Grants Breakthrough Device Designation to Holly Implantable Dialysis System

On December 15, 2025, the FDA granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system, recognizing Holly as a novel, transformative therapy addressing end-stage kidney disease. The designation was supported by data from a multi-day large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

On December 18, 2025, Takeda announced positive topline results from a pair of phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe PsO. The Latitude studies demonstrated superiority of zasocitinib compared to placebo for the coprimary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 at week 16, with a significantly greater PASI 75 response rate observed as early as week 4 and continuing to increase through week 24. Of note, the studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast.

The FDA has approved several new treatments, including lerodalcibep-liga for hypercholesterolemia, depemokimab-ulaa for severe asthma, and fibrinogen, human-chmt for congenital fibrinogen deficiency. Additionally, the Holly implantable dialysis system received Breakthrough Device Designation, highlighting its potential in treating end-stage kidney disease. Takeda's zasocitinib showed promising results in phase 3 trials for moderate-to-severe plaque psoriasis, demonstrating significant efficacy over placebo. These developments underscore ongoing advancements in therapeutic options across various medical conditions, offering new hope for patients and healthcare providers.

Stay updated with the latest healthcare breakthroughs, including FDA news and phase 3 trial readouts, in this week's essential news roundup.

Nephrology

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

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Hematology

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.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

The HCPFive: Top News for Healthcare Providers from the Week of 12/14

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

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.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Obesity Management

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

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.

Inflammatory bowel disease (IBD) and increased body mass index (BMI) are causally linked to patients’ risk of hidradenitis suppurativa (HS), new findings suggest.

These new findings and their analysis were published in 

, with Rune Kjærsgaard Andersen, MD, PhD, from the Department of Dermatology and Allergy at Herlev and Gentofte Hospital in Denmark, as the corresponding author. Andersen et al highlighted the previous connections drawn between obesity and smoking to HS development, pointing to what had previously been a lack of a causal connection fully developed by researchers.

“To investigate our primary objective, the causal effect of the environmental exposures on HS, we performed 2-sample MR analyses of body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) and smoking on HS,” Andersen and colleagues wrote.

As a secondary aim, the investigators set out to assess a potential connection between HS and 3 inflammatory conditions: psoriasis, IBD, and systemic sclerosis (SSc).

The investigative team performed their Mendelian randomization (MR) analysis to assess the aforementioned 5 traits and HS as the study's outcome. Their analysis leveraged large genome-wide association study (GWAS) datasets which they noted were made up of individuals of White European ancestry for all phenotypes. Andersen et al noted their primary analyses were carried out in May 2024 and later given updates in May 2025.

Genetic correlation (rg), which ranges from −1 to 1 and reflects the extent of shared genetic architecture between 2 traits, was calculated by the investigators between HS and each exposure via the use of cross-trait linkage disequilibrium (LD) score regression. These analyses incorporated association statistics from approximately 1.2 million well-imputed genetic variants. Andersen and colleagues derived LD information from precomputed scores for White European populations provided by the Broad Institute.

Genome-wide significant single-nucleotide variants (SNVs) identified in the largest publicly available GWAS previously, or in consortium datasets, were implemented by the investigative team as instrumental variables for each exposure phenotype. The team collected HS data from a meta-analysis including 4814 individuals with HS and 1,216,105 control participants from Iceland, Denmark, Finland, the UK, and the US. The necessary BMI estimates were based on a White European–restricted meta-analysis of roughly 700,000 participants from the UK Biobank and the GIANT consortium.

For SSc, Andersen and coauthors used a publicly available meta-analysis of 9095 cases and 17,584 control participants of White European descent was used. Data on psoriasis came from a meta-analysis including 39,498 cases and 286,769 controls. Smoking-related genetic instruments were derived from a large analysis which looked into ever-regular smokers with never-regular smokers, encompassing 1,232,091 subjects. IBD data were sourced from the International IBD Genetics Consortium and included 38,155 cases and 48,485 controls.

Overall, the investigative team's genetic correlation analyses demonstrated significant shared genetic liability between HS and all exposures except SSc. They found positive correlations for BMI (rg = 0.36, 

 < .001), smoking (rg = 0.33, P < .001), and psoriasis (rg = 0.34, 

 < .001). Conversely, the correlation with SSc was shown not to be statistically significant (rg = 0.33, 

Andersen et al's MR results supported a causal link between increased BMI and higher risk of HS, with the investigators pointing to an estimated effect size of β = 0.87, corresponding to an OR of 1.20 per unit increase in BMI (95% CI, 1.17–1.23; 

 < .001). In their sensitivity analyses, Andersen and colleagues did not identify evidence of directional pleiotropy (slope β = 0.91, 

 = .76). They also noted smoking initially demonstrated a significant causal estimate (β = 0.59, 

 < .001), but added the link was attenuated and became less definitive in sensitivity analyses.

Among the remaining immune-mediated conditions assessed by Andersen and coauthors, the data supported a causal role for IBD in development of HS (β = 0.18; OR = 1.20; 95% CI, 1.15–1.24; 

 < .001), and there was no indication of pleiotropic bias.

“Although initial MR analysis also found a causal effect of smoking on HS, this disappeared during subsequent sensitivity analysis,” the team concluded.

“However, because none of the sensitivity analyses revealed signs of pleiotropic effects, the MR should be viewed as inconclusive rather than proof of no causal effect.”

Kjærsgaard Andersen R, Riis PT, Zachariae C, et al. Hidradenitis Suppurativa and Smoking, Obesity, Psoriasis, Inflammatory Bowel Disease, and Systemic Sclerosis: Results From A 2-Sample Mendelian Randomization Study. JAMA Dermatol. Published online December 17, 2025. 

Mintoff D, Agius R, Pace NP, et al. Obesity and hidradenitis suppurativa: targeting meta-inflammation for therapeutic gain. Clin Exp Dermatol. 2023 Aug 25;48(9):984-990. doi: 10.1093/ced/llad182. PMID: 37171791.

Happle R, König A. A lesson to be learned from Karl Marx: smoking triggers hidradenitis suppurativa. Br J Dermatol. 2008 Jul;159(1):255-6; author reply 256-7. doi: 10.1111/j.1365-2133.2008.08604.x. Epub 2008 Jul 1. PMID: 18489595.

New research indicates a causal link between inflammatory bowel disease (IBD), increased body mass index (BMI), and the risk of hidradenitis suppurativa (HS). The study utilized Mendelian randomization (MR) analysis, leveraging large genome-wide association study datasets. Significant genetic correlations were found between HS and BMI, IBD, smoking, and psoriasis, but not systemic sclerosis (SSc). The findings suggest a causal role for increased BMI and IBD in HS development, while the initial causal link between smoking and HS was not supported in sensitivity analyses.

This study explored the potential impact of body mass index (BMI) and smoking on patients’ risk of developing hidradenitis suppurativa.

Hidradenitis Suppurativa

Hidradenitis Suppurativa 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 dermatology research, treatment, and drug development.

BMI, Inflammatory Bowel Disease Both Show Causal Effect on HS Development

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.

The US Food and Drug Administration has approved Cytokinetics’ aficamten (Myqorzo) 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

According to a December 19, 2025, press release from the Company, the approval is based on positive results from the phase 3 SEQUOIA-HCM clinical trial demonstrating robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints. Of note, the full US Prescribing Information for aficamten includes a Boxed Warning for the risk of heart failure.

“HCM is a heart muscle disease associated with a significant symptom burden. This approval of a new drug, [aficamten], represents a meaningful addition to the treatment options available for symptomatic obstructive HCM patients,” Martin Maron, MD, Director, Hypertrophic Cardiomyopathy Center, Lahey Hospital and Medical Center, and Principal Investigator of SEQUOIA-HCM, said in a statement.

 “In SEQUOIA-HCM, [aficamten] improved exercise capacity and reduced symptoms while also being well-tolerated. For these reasons, [aficamten] represents an important step forward in how we care for people living with obstructive HCM.”

Aficamten is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with aficamten reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.

Results from SEQUOIA-HCM showed treatment with aficamten for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.8 mL/kg/min compared to baseline in patients treated with aficamten versus 0.0 mL/kg/min in patients treated with placebo (least square mean (LSM) difference, 1.74 mL/kg/min; 95% CI, 1.04-2.44]; 

= .000002). The treatment effect of aficamten was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy.

In the trial, aficamten was well-tolerated with no instances of worsening heart failure or treatment interruptions due to low LVEF. Treatment emergent serious adverse events occurred in 5.6% of patients on aficamten and 9.3% of patients on placebo.

Core laboratory echocardiographic LVEF was observed to be <50% in 5 patients (3.5%) on aficamten compared to 1 patient (0.7%) on placebo. Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on aficamten than on placebo. Aficamten-associated increases in blood pressure are consistent with relief of LVOT obstruction and improved cardiac output.

As described in the press release, aficamten includes a Boxed Warning for the risk of heart failure. Cytokinetics notes aficamten reduces LVEF and can cause heart failure due to systolic dysfunction. Therefore, echocardiogram assessments are required prior to and during treatment with aficamten to monitor for systolic dysfunction, and initiation of aficamten in patients LVEF <55% is not recommended.

The release instructs providers to decrease the dose of aficamten if LVEF <50% and ≥40% and to interrupt the dose of aficamten if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction. Because of the risk of heart failure due to systolic dysfunction, aficamten is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.

“Living with symptomatic obstructive HCM means managing physical limitations and burdensome symptoms every day of your life,” said Lisa Salberg, Founder and CEO of the Hypertrophic Cardiomyopathy Association.

 “For far too long, we’ve had few options to address our needs, and the approval of [aficamten] is a long-awaited and major addition to bring new hope to patients living with oHCM. We are so grateful to the team at Cytokinetics for listening to the patient community and working in true partnership to bring this therapy to so many in need.”

Cytokinetics. Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms. December 19, 2025. Accessed December 19, 2025. 

https://ir.cytokinetics.com/press-releases/press-release-details/2025/Cytokinetics-Announces-FDA-Approval-of-MYQORZO-aficamten-for-the-Treatment-of-Adults-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-to-Improve-Functional-Capacity-and-Symptoms/default.aspx

Campbell P. Aficamten Showcases oHCM Benefit in Phase 3 SEQUOIA-HCM Trial. HCPLive. May 13, 2024. Accessed December 19, 2025. 

https://www.hcplive.com/view/aficamten-showcases-ohcm-benefit-in-phase-3-sequoia-hcm-trial

The FDA has approved Cytokinetics' aficamten for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults, enhancing functional capacity and symptoms. This approval follows positive phase 3 SEQUOIA-HCM trial results, demonstrating significant improvements in exercise capacity and symptom reduction. Aficamten, an allosteric inhibitor of cardiac myosin, reduces cardiac contractility and LVOT obstruction. Despite its efficacy, aficamten carries a Boxed Warning for heart failure risk, necessitating echocardiogram monitoring. It is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

The approval is based on phase 3 SEQUOIA-HCM clinical trial. The full US Prescribing Information includes a Boxed Warning for the risk of heart failure.

Cardiomyopathy

FDA News

FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

Videos

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.


Video Series

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.

Rheumatology

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.

 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

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

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.

This Year In Medicine

 Topical Steroid Withdrawal: Inside the Controversy Over TSW in Dermatology

Maria Hordinsky, MD, is an R.W. Goltz Professor of the Department of Dermatology at the University of Minnesota.

Cosmo Pharmaceuticals released pivotal phase 3 findings on clascoterone treatment, a potential first-in-class medication designed to target androgenetic alopecia.

Alopecia

Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD

In a new study, children exposed to gestational diabetes showed lower FEV1 and increased odds of current asthma at ages 8–9 years.

Type 1 Diabetes

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Gestational Diabetes Linked to Reduced Lung Function in Children

A cross-sectional study indicates a link between urinary levels of measured metals and metalloids and the stages of cardiovascular-kidney-metabolic syndrome.


Chronic Kidney Disease

Metal Exposure Levels May Explain Cardiovascular-Kidney-Metabolic Stages

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.

Al-Samkari discusses the slew of HHT-related complications, their frequency, and their severity, highlighting the need for more active intervention.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Latest News

Heated Milk Desensitization Offers No Clear Advantage Over Raw Milk in Children

The HCPFive: Top News for Healthcare Providers from the Week of 12/14

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

BMI, Inflammatory Bowel Disease Both Show Causal Effect on HS Development

FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy