Story perspectives

FDA Expands WINREVAIR Approval, Boosting PAH Treatment Efficacy

10/28/2025

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Summary

Story summary

The United States Food and Drug Administration expanded WINREVAIR (sotatercept-csrk) approval for adults with PAH to improve exercise capacity.
It also reduces clinical worsening, including hospitalization and death, per Phase 3 ZENITH data.
ZENITH enrolled 172 participants and showed a 76% reduction in morbidity and mortality.
Adverse reactions included infections and epistaxis; monitoring of hemoglobin and platelets is advised; WINREVAIR is the first activin signaling inhibitor approved for PAH.

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Story summary

The United States Food and Drug Administration expanded WINREVAIR (sotatercept-csrk) approval for adults with PAH to improve exercise capacity.
It also reduces clinical worsening, including hospitalization and death, per Phase 3 ZENITH data.
ZENITH enrolled 172 participants and showed a 76% reduction in morbidity and mortality.
Adverse reactions included infections and epistaxis; monitoring of hemoglobin and platelets is advised; WINREVAIR is the first activin signaling inhibitor approved for PAH.