Adults with pulmonary arterial hypertension (PAH) have a new treatment available with the FDA approval of sotatercept (Winrevair; Merck), an activin signaling inhibitor biologic.
Sotatercept-csrk is the first approved activin signaling inhibitor therapy for pulmonary arterial hypertension, which represents a new class of therapy.
The FDA has issued a Prescription Drug User Fee Act fate of March 26, 2024, for sotatercept (Merck) as treatment for adults with pulmonary arterial hypertension.
Application based on clinically meaningful results from the Phase 3 STELLAR trial
If approved, sotatercept would be the first in its class, bringing a novel approach to address a rare and.