FDA approves Merck’s Winrevair for PAH treatment
Betsy Goodfellow | March 27, 2024 | News story | Medical Communications | Cardiology, FDA, Merck, Winrevair, pulmonary arterial hypertension
Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) has approved Winrevair (sotatercept-csrk) for the treatment of adult patients with pulmonary arterial hypertension (PAH).
The drug is intended to increase exercise capacity, improve World Health Organization (WHO) functional class (FC) and reduce risk of clinical worsening events.
The drug was previously granted Breakthrough Therapy Designation by the FDA, and is the first activin signaling inhibitor therapy for PAH to be approved by the FDA.
This approval is based on results from the phase 3 STELLAR trial, which assessed Winrevair compared to placebo, both in combination with background standard-of-care therapies. The trial demonstrated that adding Winrevair to background therapy increased six-minute walk distance as well as significantly improving multiple secondary endpoints such as reducing risk of death from any cause or PAH worsening events by 84% compared to background therapy alone.
Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, commented: “PAH remains a debilitating disease with high morbidity and mortality. This approval of WINREVAIR is an important milestone and a testament to our science-led strategy and focus on the development of innovations that can help people affected by rare diseases like PAH. We are proud to bring this novel medicine to patients.”
Dr Marc Humbert, professor of medicine and director of the pulmonary hypertension reference centre at the Université Paris-Saclay, France, and investigator on the phase 3 STELLAR study, added: “PAH is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart. Based on the phase 3 STELLAR trial, adding Winrevair to background PAH therapy demonstrated significant clinical benefits compared to background PAH therapy alone. This approval is an important milestone, as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway.”
Betsy Goodfellow
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