MSD Receives FDA Approval for Winrevair's Updated Indication
MSD has received US FDA approval for an updated indication of Winrevair by injection to treat adults with pulmonary arterial hypertension.
In the trial involving 172 patients, Winrevair showed a 76% reduction in major mortality or morbidity risk.
Approval Details
MSD has received US Food and Drug Administration (FDA) approval for an updated indication of Winrevair (sotatercept-csrk) for injections of 45mg and 60mg for pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I).
Clinical Trial
The approval is based on data from the Phase III global, placebo-controlled, double-blind, multicentre, parallel-group Zenith trial.
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Author's summary: MSD's Winrevair receives FDA approval for PAH treatment.
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