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默克获得FDA同意扩大Winrevair标签

2025-10-27 21:15

Merck (NYSE:MRK) has received approval from the U.S. FDA for an updated product label for Winrevair (sotatercept), available in 45mg and 60mg injections, aimed at treating adults with pulmonary arterial hypertension.
This new approval broadens the use of Winrevair to include serious clinical events related to pulmonary arterial hypertension, such as hospitalizations, lung transplants, and fatalities.
The label update is supported by findings from the phase 3 ZENITH trial, which evaluated the efficacy of Winrevair in patients with this condition.

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