Drugs

Merck Winrevair sBLA Seeks Updated Label on Risk Reduction

FDA has accepted for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update the drug’s U.S. label to include data from the Phase 3 ZENITH trial, which demonstrated a significant reduction in mortality and morbidity among patients with pulmonary arterial hypertension (PAH). Approved in 2024, Winrevair is currently indicated for adults with PAH (World Health Organization Group 1) to improve exercise capacity, WHO functional class, and to reduce the risk of clinical worsening. The agency has set a user fee review action target date of 10/25.

The submission is based on data from the ZENITH trial, which showed a 76% reduction in the risk of a composite endpoint of all-cause death, lung transplantation, and PAH-related hospitalizations compared to placebo, according to Merck. ZENITH was the first Phase 3 PAH trial to use a primary endpoint solely composed of major morbidity and mortality events and was stopped early due to “overwhelming efficacy,” it says. The safety profile in ZENITH remained consistent with earlier studies. Results from the trial were recently published in the New England Journal of Medicine.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome