FDA greenlights first-in-class treatment for PAH

FDA has approved sotatercept-csrk (Winrevair) for the treatment of adults with pulmonary arterial hypertension (PAH; WHO Group 1) to increase exercise capacity, improve WHO functional class, and reduce risk of clinical worsening events. Sotatercept is a recombinant activin receptor type IIA-Fc fusion protein designed to inhibit activin signaling, thereby improving the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. Approval was based on results from the phase 3 STELLAR trial involving 323 patients with PAH.