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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