Shots:
- The US FDA has approved Winrevair to treat adults with PAH (WHO Group 1) functional class (FC) II or III
- Approval was based on the global P-III (ZENITH) trial (N=172) evaluating Winrevair (n=86; 0.7 mg/kg; SC; Q3W) + background therapy vs PBO (n=86) in adults with PAH (WHO FC III/IV) at high mortality risk. WINREVAIR showed a 76% reduction in major morbidity and mortality risk vs PBO, 1EP events occurred in 17% vs 55% pts. The trial was stopped early for efficacy, and participants transitioned to an open-label extension
- Winrevair is FDA-approved for adults with PAH (WHO Group 1) to improve exercise capacity, WHO FC, and reduce clinical worsening, hospitalization, lung transplantation, and death
Ref: Merck | Image: Merck | Press Release
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