Committee supports broader Winrevair use for PAH in Europe
Treatment indication would expand beyond improving exercise capacity
A committee of the European Medicines Agency (EMA) has recommended expanding the indication for Winrevair (sotatercept-csrk), Merck’s approved injection therapy for adults with pulmonary arterial hypertension (PAH).
Winrevair was approved in the European Union last year. It is currently indicated for use in combination with other PAH therapies to improve exercise capacity in PAH patients who have World Health Organization (WHO) functional class 2 or 3.
Now, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending that the approval be expanded to authorize Winrevair in combination with other PAH therapies as a treatment for adults with PAH who have WHO functional class 2, 3, or 4.
“If approved, this broader indication would recognize the impact of WINREVAIR on morbidity and mortality in adult patients with PAH, extending the overall use of WINREVAIR to be inclusive of WHO [functional class] II, III and now IV patients, with a treatment objective beyond the improvement of exercise capacity,” Joerg Koglin, MD, PhD, senior vice president and head of general medicine, global clinical development at Merck Research Laboratories, said in a company press release. Merck is known as MSD outside of the United States and Canada.
Final decision by European Commission expected in early 2026
A final decision from the European Commission (EC) is expected in early 2026. The EC isn’t required to follow the CHMP’s recommendations, but it almost always does. EC approvals apply to all member states of the EU, as well as Iceland, Liechtenstein, and Norway.
“We look forward to the EC’s decision as we work to ensure broad patient access to the first and only activin signaling inhibitor therapy approved in Europe and continue to deliver meaningful evidence to support treatment decisions,” Koglin said.
PAH is characterized by high blood pressure in the vessels that supply blood from the heart to the lungs, which places a strain on the heart. In PAH, high pressure in these vessels is driven by the abnormal growth of cells that line the blood vessels, which causes the cells to become abnormally narrowed. Winrevair, which is administered by injection under the skin every three weeks, is designed to reduce the activity of signaling molecules that drive this abnormal cell growth.
The original approval of Winrevair in Europe was primarily based on data from the Phase 3 STELLAR trial (NCT04576988), which evaluated the therapy against a placebo in adults with PAH in WHO functional class 2 or 3. Results showed Winrevair significantly increased the distance patients could walk in six minutes, a standard measure of exercise capacity.
The CHMP’s recommendation to expand Winrevair’s approval is based on data from a more recent Phase 3 clinical trial called ZENITH (NCT04896008), which tested Winrevair against a placebo in adults with PAH in WHO functional class 3 or 4. Results, published earlier this year, showed that Winrevair treatment significantly reduced the risk of death, lung transplant, or hospitalization. The results were so unambiguous that the study was ended earlier than planned, allowing patients on the placebo to switch to the therapy.
Recently, the U.S. Food and Drug Administration (FDA) updated Winrevair’s prescribing information to state that the therapy can reduce the risk of lung transplant, hospitalization for PAH, and death.
About the Author
