Merck's Sotatercept (Winrevair) Receives FDA Approval for Expanded Indication in Pulmonary Arterial Hypertension, Reducing Risk of Morbidity or Mortality by 76%

Sotatercept is an ACVR2A-Fc fusion protein, composed of the extracellular domain of human Activin receptor IIA fused with the Fc domain of IgG1, which can bind and capture TGF-β family ligands, thereby restoringBMPR-IIThe balance of signaling pathways. Since the imbalance of BMPR-II signaling is a driving factor of PAH, Sotatercept achieves its therapeutic purpose through this mechanism.

In September 2021, MSD acquired Acceleron Pharma for $11.5 billion, gaining access to Sotatercept. In March 2024, the drug was approved by the FDA for marketing based on the results of the Phase III STELLAR study, for the treatment ofWHO FC Class II or III PAHAdult patients, to enhance exercise capacity, improve WHO FC, and reduce the risk of clinical worsening events.

This new indication approval is based onPositive Results from Phase III ZENITH Study. This study is a randomized, double-blind, placebo-controlled clinical trial (n=172) that evaluatedEfficacy and Safety of Sotatercept (Starting Dose 0.3mg/kg, Target Dose 0.7mg/kg, Subcutaneous Injection, Once Every 3 Weeks) vs Placebo in FC III or IV PAH Patients with High Mortality Risk Receiving Maximum Tolerated Background Therapy. The primary endpoint of the study isThe time of the first confirmation of the onset or death event (all-cause mortality, lung transplantation, or hospitalization for ≥24 hours related to PAH deterioration).

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