European Commission approval for Winrevair (sotatercept) in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with functional class II-III

Winrevair is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. Winrevair works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. The EC approval of Winrevair is based on safety and efficacy results from the Phase III STELLAR trial.

“The European Commission’s approval of Winrevair is an important step for patients,” said Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories. “Winrevair is the first therapy targeting the activin signaling pathway. We are proud to bring this innovative treatment to more patients and remain committed to further investigating the potential of Winrevair in areas where there are unmet needs in the management of PAH.”

“Pulmonary arterial hypertension is a devastating disease for patients, who suffer from debilitating symptoms that can severely limit their daily activities,” said Dr. Marc Humbert, Professor of Medicine and Director of the Pulmonary Hypertension Reference Center at Université Paris-Saclay. “New treatment opinions continue to be needed for patients. Based on the Phase III STELLAR study, adding Winrevair to background PAH therapy improved exercise capacity, reduced the risk of death or clinical worsening events and improved functional class compared to background PAH therapy alone. These findings are significant and reinforce that Winrevair, in combination with other PAH therapies, should be considered as a new standard of care for the treatment of functional class II and III adult patients.”

The EC approval is based on the Phase III STELLAR trial, which compared Winrevair (n=163) to placebo (n=160), both in combination with background standard of care therapies in adult patients with PAH (WHO Group 1, FC II or III). The primary efficacy endpoint was change from baseline at Week 24 in six-minute walk distance. Treatment with Winrevair resulted in a statistically significant and clinically meaningful improvement in six-minute walk distance of 40.8 meters over placebo (95% CI: 27.5, 54.1; p<0.001). winrevair also significantly improved multiple important secondary outcome measures, including reducing the risk of death or clinical worsening. in a post hoc analysis provided to ema, time to death or clinical worsening was defined as the time from randomization to the first occurrence of deterioration of pah, pah-specific hospitalization, worsening-related listing for lung and or heart transplant, need for atrial septostomy, or death from any cause. there was an 82% reduction in the risk of death or clinical worsening with winrevair on top of background therapy versus background therapy alone (number of events: 7 vs 29, hr="0.182;" 95% ci: 0.075, 0.441; p><0.001).

Winrevair is administered once every 3 weeks as a single injection under the skin and may be administered by patients or caregivers with guidance, training and follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Instructions for Use for information on the proper preparation and administration of Winrevair.