Tuesday, July 16, 2024

Merck’s Sotatercept for PAH gets FDA Priority Review

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Merck, also known as MSD outside of the United States and Canada, has achieved priority review status from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) concerning sotatercept. This innovative activin signaling inhibitor is under evaluation for the treatment of pulmonary arterial hypertension (PAH) in adult patients, a rare and life-threatening condition characterized by the narrowing of lung blood vessels, leading to strain on the heart.

The FDA has designated a target action date of March 26, 2024. The application draws from promising outcomes in Phase 3 STELLAR trial, where the sotatercept displayed significant enhancements across various parameters, offering a potential new avenue for addressing this challenging disease. If approved, sotatercept would represent a groundbreaking treatment for PAH, as it would be the first of its kind in this category.

PAH is a rare, progressive condition with a five-year mortality rate of approximately 43%, significantly impacting patients’ quality of life and longevity. Merck’s innovative approach offers hope for improving outcomes in this patient population.

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