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 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).
The FDA update adds clarification to the indication, stating Winrevair reduces the risk of clinical worsening events.
Winrevair was initially approved by the FDA to improve exercise capacity, improve World Health Organization (WHO) functional class, and reduce the risk of clinical worsening events in adults with PAH.
Author's summary: FDA updates Winrevair's prescribing information.