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Merck Says Pulmonary Arterial Hypertension Treatment Update Gets FDA Approval
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Merck Says Pulmonary Arterial Hypertension Treatment Update Gets FDA Approval
Oct 27, 2025 4:39 AM

07:25 AM EDT, 10/27/2025 (MT Newswires) -- Merck ( MRK ) said Monday it received approval for an update for Winrevair, a treatment for adults with pulmonary arterial hypertension, from the US Food and Drug Administration.

The approval expands the indication of the drug to include components of clinical worsening events such as hospitalization, lung transplantation, and death, Merck ( MRK ) said.

The latest approval was based on a phase 3 trial that showed a statistically significant 76% reduction in the risk of major morbidity and mortality outcomes in adults with the disease compared to placebo, the company said.

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