FDA approves Merck drug sotatercept for rare, deadly lung condition

From CNBC: 2024-03-26 17:13:44

The FDA approved Merck’s Winrevair treatment for pulmonary arterial hypertension, a life-threatening lung condition. The drug targets the root cause and is a milestone for patients with the disease. Merck estimates it will reach $5 billion in sales by 2030. Patients can self-inject Winrevair, providing a unique advantage over current treatments.

Winrevair’s approval is significant for Merck as it diversifies revenue with the impending loss of exclusivity for Keytruda. The FDA’s approval was based on a trial where Winrevair combined with existing therapy significantly improved patients’ ability to exercise and reduced the risk of death or worsening condition by 84%.

The drug will cost $14,000 per vial before insurance, but Merck offers assistance programs for eligible patients. The convenience of self-injection makes Winrevair an attractive option for patients and physicians. Merck plans to continue studying Winrevair in more advanced PAH patients to further evaluate its efficacy.



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