Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)
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- The approval was based on the results from the P-III (STELLAR) trial evaluating Winrevair (0.7mg/kg) vs PBO + stable background therapy (SC, Q3W) in patients (n=163 vs 160) with PAH. The 1EP was change from baseline at wk.24 in 6MWD
- The results depicted a 41m median increase in 6MWD with Winrevair vs PBO along with an improvement in FC at wk.24 in 29% vs 14% of patients, an 84% reduction in the occurrence of death or PAH clinical worsening events, and improvement in PVR & NT-proBNP levels from baseline with Winrevair vs PBO
- Winrevair is an activin signaling inhibitor therapy that improves the balance between pro-proliferative & anti-proliferative signaling to modulate vascular proliferation. The US FDA earlier granted BTD to Winrevair
Ref: Merck | Image: Merck
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
