Winrevair label now clarifies reduced risk of PAH hospitalization
FDA update also specifies reduced risk of lung transplant, death
The U.S. Food and Drug Administration (FDA) has approved updated prescribing information for Merck‘s Winrevair (sotatercept-csrk) that more specifically details how the pulmonary arterial hypertension (PAH) therapy reduces the risk of serious complications.
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 new update adds clarification to the last part of this indication, specifically stating Winrevair reduces the risk of clinical worsening events including hospitalization for PAH, lung transplant, and death.
Winrevair performed strongly in clinical trials
The update “represents another step forward in our mission to deliver on the promise of Winrevair,” Joerg Koglin, MD, PhD, senior vice president of global clinical development at Merck Research Laboratories, said in a company press release.
“For patients with PAH, the risk of serious events such as hospitalization, transplantation, or death remains unacceptably high despite being maximally treated with traditional therapies,” said Vallerie McLaughlin, MD, a paid consultant for Merck and director of the pulmonary hypertension program at the University of Michigan in Ann Arbor.
PAH is marked by the abnormal growth of cells that line the blood vessels that carry blood from the heart through the lungs. This narrows the vessels, increasing pressure and putting strain on the heart. Winrevair is an under-the-skin injection therapy designed to block the activity of signaling molecules that drive abnormal cell growth, helping to slow PAH progression.
A Phase 3 clinical trial called the ZENITH trial (NCT04896008) tested Winrevair against a placebo while on background therapy in 172 adults with advanced PAH (WHO functional class 3 or 4). Results showed the therapy significantly reduced the risk of all-cause death, lung transplant, or hospitalization. The data were so decisive the trial was ended early so all participants could be given Winrevair.
Data from other Phase 3 trials, including STELLAR (NCT04576988) and HYPERION (NCT04811092), have consistently shown the therapy can reduce the risk of death and other clinical worsening events, while also improving measures of heart health and enhancing walking ability.
McLaughlin, who served as an investigator on the ZENITH trial, said results from that trial “add to the growing body of data and support the potential for Winrevair as standard of care.”
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