FDA Approves Merck's Winrevair For Treatment Of Pulmonary Arterial Hypertension In Adults

(RTTNews) - Merck & Co., Inc. (MRK) said that the U.S. Food and Drug Administration has approved sotatercept-csrk (U.S. Brand Name: Winrevair, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.

Winrevair was previously granted Breakthrough Therapy Designation by the FDA.

Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart.

Merck warned that Winrevair may increase hemoglobin and may lead to erythrocytosis, which if severe may increase the risk of thromboembolic events or hyperviscosity syndrome. Winrevair also may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion.

The company advises patients not to breastfeed while using Winrevair and for 4 months after completing the final dose due to the risk of serious adverse reactions in the breastfed child.

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