"FDA Greenlights Merck's WINREVAIR™ for Rare, Deadly Lung Condition"
The FDA has approved Merck's WINREVAIR (sotatercept-csrk) for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. WINREVAIR, a first-in-class activin signaling inhibitor therapy, demonstrated significant clinical benefits in a Phase 3 trial, including improved exercise capacity and reduced risk of death or PAH clinical worsening events. Healthcare providers should monitor hemoglobin and platelets before each dose, as WINREVAIR may increase hemoglobin and decrease platelet count. The medication is expected to be available in the U.S. by the end of April and comes with support for patients through the Merck Access Program.
- FDA Approves Merck's WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1) Merck
- FDA approves new drug that may help stop and even reverse a rare, fatal condition that doctors call a ‘ticking time bomb’ CNN
- FDA approves Merck's drug for rare, deadly lung condition CNBC
- Merck’s (MRK) Winrevair for Rare High Blood Pressure Disorder Approved by FDA Bloomberg
- Merck's $11.5 Billion Bet on Its Next Big Drug Finally Arrives The Wall Street Journal
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