FDA Updates Prescribing Information for PAH Treatment Winrevair
The U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Merck's PAH treatment Winrevair (sotatercept-csrk).
The FDA update specifies that Winrevair reduces the risk of serious complications, including hospitalization for PAH, lung transplant, and death, in adults with pulmonary arterial hypertension (PAH).
Winrevair was approved by the FDA last year to improve exercise capacity, improve World Health Organization (WHO) functional class, and reduce the risk of clinical worsening events in adults with PAH.
The update provides clarification on the reduction of clinical worsening events, including lung transplant and death.
Author's Summary
FDA updates Winrevair's prescribing information to reflect the treatment's benefits.
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