Approval Alert: MSD’s WINREVAIR™ (sotatercept-csrk) Granted FDA Approval for Treating Adults with PAH

On 26 March 2024, MSD announced that its WINREVAIR™ (sotatercept-csrk) has been approved by the FDA for treating adults with pulmonary arterial hypertension (PAH).  FDA classified WINREVAIR™ as a breakthrough therapy due to it representing a new class of therapy which functions by rebalancing proliferative signals to regulate vascular cell proliferation in PAH.  The FDA approval was based on Phase 3 STELLAR trial results which showed 84% reduction in the occurrence of death or PAH clinical worsening events in comparison to placebo.