Merck’s new application for sotatercept given priority review by FDA

Merck announced that the FDA has accepted for priority review a new Biologics License Application for sotatercept, Merck’s novel investigational activin signaling inhibitor, for the treatment of adult patients with pulmonary arterial hypertension. The FDA has set a Prescription Drug User Fee Act, or target action, date of March 26, 2024. PAH is a rare, progressive and ultimately life-threatening disease characterized by the narrowing of blood vessels in the lungs, causing significant strain on the heart. The application for sotatercept is based on data from the Phase 3 STELLAR trial, in which sotatercept on top of background therapy demonstrated a statistically significant and clinically meaningful improvement in 6-minute walk distance and eight of nine secondary outcome measures.