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 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.
- Improved exercise capacity
- Improved World Health Organization (WHO) functional class
- Reduced risk of clinical worsening events, including:
- Hospitalization for PAH
- Lung transplant
- Death
Author's summary: FDA updates Winrevair's prescribing information.
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