Drugs

Priority Review for Merck’s Winrevair

FDA has accepted and granted priority review for an sBLA seeking approval to update the label for Merck’s Winrevair (sotatercept-csrk) based on the Phase 3 ZENITH trial. A company statement says Winrevair was approved in 2024 to treat adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve World Health Organization functional class, and reduce the risk of clinical worsening events. FDA has set 10/25 as the PDUFA action date for the sBLA.

Merck says Zenith was the first PAH Phase 3 outcome study to use a primary endpoint composed entirely of major morbidity and mortality events. It was also the first PAH Phase 3 study stopped early by an independent data monitoring committee for overwhelming efficacy, the company says.

In Zenith, Winrevair demonstrated a 70% reduction in the risk of a composite of all-cause death, lung transplantation, and hospitalization for PAH ≥ 24 hours compared to placebo. Merck says improvement was observed early in treatment, with increasing benefit throughout the study. It says the safety profile in ZENITH was generally consistent with that observed in previous studies.

Winrevair is described as the first activin signaling inhibitor therapy approved to treat PAH. It is said to improve the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, Merck says, Winrevair induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

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

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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