Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Image Credit: US Food and Drug Administration

Announced by parent company Agios on December X, 2025, the 

 has approved mitapivat under the brand name AQVESME for the treatment of anemia in adults with alpha- or beta-thalassemia.

"Despite its severity, treatments [for thalassemia] have historically been limited, leaving some patients without any options," Hanny Al-Samkari, MD, Peggy S. Blitz Endowed Chair in Hematology/Oncology at Massachusetts General Brigham Cancer Institute and associate professor at Harvard Medical School, said in a statement. "The ENERGIZE and ENERGIZE-T Phase 3 trial results demonstrate that AQVESME can help address anemia, fatigue, and the need for regular transfusions - key challenges of the disease."1

Mitapivat is a small-molecule oral activator of pyruvate kinase R (PKR), which is involved in maintaining the energy, health, and longevity of red blood cells. Mitapivat improves red blood cell survival in 

 by increasing ATP and diminishing sickling via decreases in 2,3-diphosphoglycerate.

The FDA’s decision was based on results from the phase 3 ENERGIZE and ENERGIZE-T trials. ENERGIZE was a double-blind, randomized, placebo-controlled trial conducted across 70 hospitals in 18 countries globally. For inclusion, patients had to be ≥18 years with non-transfusion-dependent alpha- and beta-thalassemia and hemoglobin concentrations of ≤10 g/dL.

In ENERGIZE, patients were randomly assigned in a 2:1 ratio to either mitapivat or placebo, both of which were administered at 100 mg orally twice a day for 24 weeks. The primary endpoint was the change in hemoglobin response from baseline.

Ultimately, 194 patients were enrolled, with 130 assigned to mitapivat and 64 to placebo. A total of 7 patients receiving mitapivat and 1 receiving placebo discontinued treatment. 55 patients in the mitapivat group had a hemoglobin response, compared to 1 in the placebo group (least-squares mean difference, 41%; 95% CI, 32-50; 

 <.0001). Adverse events were reported in 107 patients in the mitapivat arm versus 63 in the placebo arm, with the most common being headache, initial insomnia, nausea, and upper respiratory tract infection. No deaths were reported.

The ENERGIZE-T trial was a global, double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of mitapivat versus placebo in adults with transfusion-dependent alpha- or beta-thalassemia. Investigators randomly assigned patients ≥18 years in a 2:1 ratio to mitapivat 100 mg or placebo twice daily for 48 weeks.

ENERGIZE-T's primary endpoint was transfusion reduction response (TRR), defined as a ≥50% reduction in transfused red blood cell (RBC) units and a reduction of ≥2 units of transfused RBCs in any consecutive 12-week period compared with baseline. Key secondary endpoints were TRR2, a ≥50% reduction from baseline in transfused RBC units in any consecutive 24-week period, TRR3, a ≥33% reduction from baseline in transfused RBC units in weeks 13-48, and TRR4, a ≥50% reduction from baseline in transfused RBC units at weeks 13-48.

A total of 258 patients were randomized, with 171 assigned to mitapivat and 87 to placebo. A TRR was achieved in 30.4% of patients in the mitapivat arm versus 12.6% in the placebo arm. Additionally, statistically significant reductions in transfusion burden were demonstrated by all key secondary endpoints: 13.5% versus 2.3% achieved TRR2; 14.6% versus 1.1% achieved TRR3; 7.6% versus 1.1% achieved TRR4.

"Today is a landmark moment for the thalassemia community, bringing forward an innovative, disease-modifying oral medicine to address the urgent needs of people living with this devastating rare blood disorder," Brian Goff, chief executive officer of Agios, said in a statement. "With this approval, AQVESME becomes the only medicine indicated for the treatment of anemia in both non-tranfusion-dependent and transfusion-dependent alpha- or beta-thalassemia."1

Agios Pharmaceuticals. US FDA Approves Agios' AQVESME (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia. December 23, 2025. Accessed December 24, 2025. 

https://investor.agios.com/news-releases/news-release-details/us-fda-approves-agios-aqvesmetm-mitapivat-treatment-anemia

Agios Pharmaceuticals. Agios Announces Topline Results from RISE UP Phase 3 Trial of Mitapivat in Sickle Cell Disease. November 19, 2025. Accessed December 5, 2025. 

https://investor.agios.com/news-releases/news-release-details/agios-announces-topline-results-rise-phase-3-trial-mitapivat

Taher AT, Al-Samkari H, Aydinok Y, et al. Mitapivat in adults with non-transfusion-dependent α-thalassaemia or β-thalassaemia (ENERGIZE): A phase 3, International, randomised, double-blind, placebo-controlled trial. The Lancet. 2025;406(10498):33-42. 

Cappellini MD, Sheth S, Taher AT, et al. Energize-T: A global, phase 3, double-blind, randomized, placebo-controlled study of mitapivat in adults with transfusion-dependent alpha- or beta-thalassemia. Blood. 2024;144(Supplement 1):409-409. 

Articles

The FDA has approved mitapivat, branded as AQVESME, for treating anemia in adults with alpha- or beta-thalassemia. This approval is based on the ENERGIZE and ENERGIZE-T Phase 3 trials, which demonstrated significant improvements in hemoglobin levels and reductions in transfusion needs. Mitapivat, an oral activator of pyruvate kinase R, enhances red blood cell survival by increasing ATP levels. The trials showed a notable hemoglobin response and transfusion reduction in patients treated with mitapivat compared to placebo, marking a significant advancement in thalassemia treatment options.

The FDA has approved small-molecule pyruvate kinase R activator mitapivat for the treatment of sickle cell anemia.

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FDA Approves Mitapivat (AQVESME) for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia

Stone is professor of medicine at Harvard Medical School and the Edward A Fox Chair in Medicine at the Massachusetts General Hospital. He has treated IgG4-related disease (IgG4-RD) since its emergence in recent years and is passionate about educating patients and fellow healthcare providers (HCPs) about the indolent and systemic nature of this disease.

Current Standards of Care in GCA Treatment

This video covers the following questions:

Let’s shift to discuss current treatments. What is the standard of care for GCA? 

While glucocorticoids have been standard of care for patients with GCA, they are known to elevate the risk of cardiovascular, metabolic, and osteoporotic complications. Please share what you have seen in your clinic.

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Current Standards of Care in GCA Treatment 

The Physical and Mental Quality of Life Impacts of GCA

How does GCA impact patient quality of life, particularly in terms of their day-to-day experience? (

What are some of the most significant long-term complications associated with untreated or poorly managed GCA?

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 Omeros Corporation’s narsoplimab-wuug (Yartemlea) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

According to a December 24, 2025, release from the Company, the decision makes narsoplimab the first and only approved lectin pathway inhibitor and is approved for use in adults and in children ≥ 2 years of age.

“This approval is a long-awaited breakthrough in hematopoietic cell transplantation and TA-TMA care,” Miguel-Angel Perales, MD, chief of the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, said in a statement.1 “Until now, we’ve lacked an effective TA-TMA therapy and relied largely on supportive measures such as modifying calcineurin inhibitors, which can significantly increase the risk of life-threatening graft-versus-host disease. Based on a compelling data package, narsoplimab delivers robust response rates and improved survival in TA-TMA, with a favorable benefit-risk profile and a safety profile consistent with that seen in patients undergoing hematopoietic stem cell transplantation. As the first and only drug approved for TA-TMA, narsoplimab is a practice-changing advance for patients facing this devastating complication.”

Narsoplimab is a fully human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Inhibition of MASP-2 has been demonstrated to leave intact the antibody-dependent classical complement activation pathway, a critical component of the acquired immune response to infection.

Omeros’ first Biologics License Application for narsoplimab was met with a Complete Response Letter in which the FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information would be needed to support regulatory approval.

The Company later filed a Class 2 resubmission with the Agency with data from a primary set of analyses comparing overall survival for narsoplimab-treated patients to overall survival for an external control group of TA-TMA patients showing clinically meaningful and statistically significant improvements in survival associated with narsoplimab treatment. Also included in the resubmission were data describing survival in Omeros’ expanded access program in which adult and pediatric TA-TMA patients were treated with narsoplimab.

Its December 24, 2025, approval was based on results from a single-arm, open-label study in adults with TA-TMA (the TA-TMA Study; n = 28), supported by additional data from an expanded access program (EAP; n = 221 adult and pediatric patients). In the EAP, 19 patients (13 adult and 6 pediatric) had evaluable patient-level response data.

Efficacy was assessed by TMA complete response (CR), defined as improvement in key laboratory markers of TMA (platelet counts and LDH levels) together with either improved organ function or transfusion independence. CR was achieved in 17 out of 28 patients (61%) in the TA-TMA Study and 13 out of 19 evaluable EAP patients (68%). Across the TA-TMA Study and the EAP, 100-day survival from the time of TMA diagnosis (based on all-cause mortality) was 73% (95% confidence interval [CI], 52-86) and 74% (95% CI, 48-88), respectively. All patients met international harmonization criteria for high-risk TA-TMA, classifying each patient as having a poor prognosis and high risk of death.

In peer-reviewed publications, treatment with narsoplimab was associated with a 3- to 4- fold reduced risk of mortality compared with an external control cohort.1 In the EAP, narsoplimab was used both as first-line therapy and in high-risk TA-TMA patients who had failed or discontinued one or more prior regimens, namely off-label complement inhibitors and/or defibrotide. In these previously refractory high-risk patients, narsoplimab was associated with 50% 1-year survival, compared with historical 1-year survival rates reported as < 20%.

As described in the release, all patients in the TA-TMA Study had multiple risk factors for poor outcomes, and adverse reactions were reported regardless of causality or relatedness to narsoplimab. The most common adverse reactions (≥20%) were viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, and hypokalemia.

Serious adverse reactions occurred in 61% of narsoplimab-treated patients; those reported in >5% included acute kidney injury, confusional state, acute respiratory failure, neutropenic sepsis, septic shock, pulmonary edema, and vomiting. Fatal adverse reactions were reported in 7% of patients, including neutropenic sepsis and septic shock. No new clinically significant safety signals were identified in patients treated with narsoplimab in the EAP.

Of note, narsoplimab has no Boxed Warning and no Risk Evaluation and Mitigation Strategy (REMS), and vaccinations are not required prior to treatment.

“Just as in adults, [narsoplimab]’s indication to treat TA-TMA in children two years of age and older is tremendously important,” said Michelle Schoettler, MD, assistant professor of Pediatric Oncology and Hematopoietic Cellular Therapy at Emory University.

 “Peer-reviewed clinical publications in TA-TMA have steadily advanced our understanding of the disease in children – its biology, diagnostic criteria, and increasing recognition – and have revealed the limitations and risks of relying on off-label options in this setting. Across the published pediatric experience, narsoplimab has produced strong and consistent benefit, including in very high-risk children with organ dysfunction and in those who have failed prior complement-inhibition therapy… My clinical experience with narsoplimab through the expanded access program, including in very young patients, has reinforced that it needs to be readily available for children when TA-TMA emerges. With this approval, effective TA-TMA therapy can become the pediatric standard instead of the exception – and that will save children’s lives.”

Omeros Corporation. FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA. December 24, 2025. Accessed December 24, 2025. 

https://investor.omeros.com/news-releases/news-release-details/fda-approves-omeros-yartemlear-first-and-only-therapy-indicated

Omeros Corporation. Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA. October 18, 2021. Accessed December 19, 2025. 

https://investor.omeros.com/news-releases/news-release-details/omeros-receives-complete-response-letter-fda-biologics-license

Omeros Corporation. FDA Accepts Resubmission of BLA for Narsoplimab for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA) and Assigns Late September PDUFA Date. May 6, 2025. Accessed December 19, 2025. 

https://investor.omeros.com/news-releases/news-release-details/fda-accepts-resubmission-bla-narsoplimab-hematopoietic-stem-cell

The FDA has approved Omeros Corporation's narsoplimab-wuug (Yartemlea) for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children aged two and older. This marks the first approval of a lectin pathway inhibitor. Narsoplimab, a monoclonal antibody targeting MASP-2, demonstrated significant survival benefits and response rates in clinical studies. Despite initial regulatory challenges, the drug showed a favorable safety profile and efficacy in high-risk patients. Its approval is expected to transform TA-TMA treatment, particularly in pediatric cases, offering a new standard of care.

The approval indicates narsoplimab as the first and only treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy.

FDA Approves Narsoplimab (Yartemlea) As First TA-TMA Therapy

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.

Throughout 2025, a broad array of significant developments in 

, including key regulatory moves by the US Food and Drug Administration (FDA) and the publication of pivotal clinical data expanding the evidence base for existing and emerging therapeutic options in this chronic inflammatory skin condition.

Several video series and podcast episodes have, alongside these regulatory and research advances, focused on HS management, highlighting new insights and expert discussions on disease diagnostic issues, HS’s pathophysiology, and evolving approaches to treatment. In this Year in Review summary article, the editorial team has brought together some of the most impactful HS-related coverage and expert perspectives included on the 

 platform, allowing for a consolidated retrospective of the year’s major milestones.

FDA Approves Adalimumab-aaty (Yuflyma) Pediatric Indications in Hidradenitis Suppurativa, Uveitis

The FDA’s approval of adalimumab-aaty (Yuflyma) was announced in 2025 by Celltrion, expanding adalimumab-aaty’s indication along with its unbranded version to include the treatment of adolescent patients ≥ 12 years of age with HS and treating uveitis (UV) in pediatric patients ≥ 2 years of age. This recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe and autoinjector.

Adalimumab-aaty was designed as a high-concentration, low-volume, and citrate-free adalimumab biosimilar approved for the treatment of those living with rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, Crohn's disease, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, UV, and HS.

New Phase 3 Findings Demonstrate Efficacy of Povorcitinib for HS Treatment

Incyte announced new positive topline findings on povorcitinib following the pivotal phase 3 STOP-HS clinical analysis of povorcitinib, an oral small-molecule Janus Kinase (JAK) 1 inhibitor’s safety and efficacy in adult patients aged ≥18 years with moderate to severe HS. The drug is being evaluated in phase 3 research for different dermatologic conditions such as vitiligo, prurigo nodularis, and HS. Within the STOP-HS trial program, this new pair of phase 3 trials titled STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836) was conducted to assess povorcitinib’s implementation in adult patients with moderate to severe HS.

Bimekizumab Long-Term Hidradenitis Suppurativa Data Support Efficacy, Safety Profile

In February 2025, new data from the 14th Conference of the European Hidradenitis Suppurativa Foundation (EHSF) were released regarding bimekizumab (Bimzelx), with the drug being linked to sustained disease control for up to 2 years in HS. These long-term data resulted from the BE HEARD studies, and findings suggest bimekizumab use for up to 96 weeks was associated with a low rate of HS flares, reduced symptoms of HS, and improved health-related quality of life among those with moderate to severe disease. Bimekizumab demonstrated sustained efficacy in the reduction of disease symptoms and quality of life improvement over 96 weeks in BE HEARD.

HS-OBTAIN: Brivekimig Achieves Positive Results in Hidradenitis Suppurativa

Brivekimig was an HS treatment led to clinically meaningful improvements among biologic-naïve patients with the disease compared to those given a placebo at the 16-week mark, according to data presented from the HS-OBTAIN phase 2a study. The analysis demonstrated significant efficacy for this medication, with 67% of patients attaining HiSCR50 compared to 37% on placebo. These findings were released at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris.

Skin of Color Savvy: HS Management in Skin of Color, with Tiffany Mayo, MD, Steven Daveluy, MD, Jasmine Ivanna Espy

In an episode of Skin of Color Savvy: The Art and Science of Treating Patients of Color, host Tiffany Mayo, MD, spoke in a discussion about HS and its treatment in patients with diverse skin types. Mayo was joined by dermatologist Steven Daveluy, MD, and patient advocate Jasmine Ivanna Espy. Together, the 3 speakers highlighted their own perspectives, framing HS not only as a medical challenge but also a quality-of-life, public health, and equity concern in the dermatology landscape.

Evolving the HS Treatment Paradigm, Long-Term Outcomes with IL-17 Inhibition

HS is a condition known to develop through a combination of genetic predisposition and environmental exposures, involving multiple factors such as metabolic influences, immune system dysfunction, mechanical forces in body folds, and altered responses related to patient wound healing. In this video series, the panelists involved highlighted how IL-17 inhibitors have emerged as first-line treatment options for moderate to severe HS. They pointed to long-term data demonstrating sustained efficacy over 2 years.

Embracing IL-17 A/F Inhibition for Hidradenitis Suppurativa, Dermatologic Conditions

During this 5-part, expert-led video series, 2 dermatologists spoke about how the FDA approval of bimekizumab and its effect on the treatment landscape of HS. One speaker, Martina Porter, MD, vice chair of Research at Beth Israel Deaconess Medical Center, spoke with Colleen Cotton, MD, director of the Multidisciplinary Pediatric HS Clinic at Children's National Hospital, to cover the FDA’s recent approval of bimekizumab for moderate to severe HS. Their video discussion was aimed at the various challenges of managing this heterogeneous skin condition and the implications of bimekizumab as a newly approved option for treatment.

In 2025, significant advancements in hidradenitis suppurativa (HS) were made, including FDA approvals and pivotal clinical data. The FDA approved adalimumab-aaty for pediatric HS and uveitis, while phase 3 trials showed povorcitinib's efficacy in moderate to severe HS. Long-term data supported bimekizumab's sustained efficacy and safety. Brivekimig showed promising results in biologic-naïve patients. Expert discussions highlighted HS management in diverse skin types and the evolving treatment paradigm with IL-17 inhibitors. These developments underscore the progress in understanding and treating this chronic inflammatory skin condition.

Catch up on some of the biggest alopecia areata news headlines covered by HCPLive from 2025 with this ‘Year in Review’ summary.

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.

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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.

Hidradenitis Suppurativa in 2025: Year in Review

The hepatitis year in review covers FDA approvals, HBV and HDV breakthroughs, HCV label expansion, clinical guidelines, and vaccine policy changes.

Hepatology

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podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

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Diabetes Dialogue: Therapeutic Updates from the ADA 2026 Standards of Care

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

The COPD year in review highlights FDA approvals, data, and advances in 2025.

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COPD in 2025: Year in Review

Results of an exclusive Urology Times survey indicate heightened concern among older men about prostate cancer screening.

This Year In Medicine

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Dyslipidemia in 2025: Year in Review

The FDA has approved an sNDA for the FUROSCIX On-body Infusor in pediatric patients and accepted another for the FUROSCIX ReadyFlow Autoinjector.

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FDA Approves FUROSCIX On-Body Injector for Pediatric Patients, Accepts sNDA for ReadyFlow Autoinjector

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A review found increased anxiety, depression, social anxiety, and perceived stress among individuals with androgenetic alopecia compared with those without the condition.

Alopecia

Psychiatry

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Psychological Distress Greater in Patients With Androgenetic Alopecia

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.

A multinational survey suggests even slowly progressing C3G and IC-MPGN substantially affect patients, caregivers, and healthcare systems.


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C3G, IC-MPGN Report A Disruptive Burden Regardless of Slowed Disease Progression 

Explore the barriers to PCSK9 inhibitors, their underuse, and how addressing misconceptions can enhance patient outcomes in cholesterol management.

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Latest News

FDA Approves Mitapivat (AQVESME) for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia

Current Standards of Care in GCA Treatment

The Physical and Mental Quality of Life Impacts of GCA

FDA Approves Narsoplimab (Yartemlea) As First TA-TMA Therapy

Hidradenitis Suppurativa in 2025: Year in Review