FDA Expands Indication for Sotatercept-csrk in Pulmonary Arterial Hypertension
The FDA has approved an updated indication for sotatercept-csrk (WINREVAIR), an activin signaling inhibitor, for adults with pulmonary arterial hypertension (PAH) in WHO functional class III or IV.
Results from the phase 3 ZENITH trial showed that sotatercept-csrk significantly reduced the risks of death, lung transplantation, and PAH-related hospitalizations compared with placebo.
WINREVAIR was initially approved based on the pivotal STELLAR study in March 2024. Today’s approval expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death.
Author summary: FDA updates indication for sotatercept-csrk.
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