European Commission Approves Merck Treatment Combined with Other Therapies for Pulmonary Arterial Hypertension

Merck’s (known as MSD outside of the United States and Canada) Winrevair (sotatercept), in combination with other therapies for pulmonary arterial hypertension (PAH), has been approved by the European Commission (EC) for treatment of adult patients with PAH in World Health Organization (WHO) Functional Class (FC) II to III, for the purpose of improving the exercise capacity of those patients, according to a press release issued by Merck on Aug. 26, 2024 (1).

EC’s approval of Winrevair was based on a Phase III trial (STELLAR), results of which were published in the New England Journal of Medicine (2). Merck said that Winrevair is the first and only activin signaling inhibitor therapy for PAH approved in all 27 European Union member states, and additionally in Iceland, Liechtenstein, and Norway (1).

“The European Commission’s approval of Winrevair is an important step for patients,” Joerg Koglin, MD, senior vice president and head of general medicine in the global clinical development department of Merck Research Laboratories, said in the press release. “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.”

In the trial, which measured the distance of a six-minute walk by PAH patients up to 24 weeks after starting treatment, Winrevair resulted in an improvement of 40.8 meters traveled on average versus placebo. Merck said the treatment also “significantly” improved secondary outcomes such as reducing risk of death or clinical worsening—by as much as 82% with Winrevair on top of background therapy as opposed to just background therapy alone (1).

“Pulmonary arterial hypertension is a devastating disease for patients, who suffer from debilitating symptoms that can severely limit their daily activities,” Marc Humbert, MD, PhD, a professor of medicine and director of the Pulmonary Hypertension Reference Center at Université Paris-Saclay in Paris, and a leading investigator in the trial, said in the press release. “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.”

Winrevair is administered as a subcutaneous injection once every three weeks. It can be administered by patients, or caregivers, with guidance, training, and follow-up from a healthcare provider. The treatment was previously approved by FDA, in March 2024, for treatment of adults with PAH for the same reasons as EC: increased exercise capacity, reduced risk of clinical worsening events, and eventual improvement of a patient’s WHO FC (1).

References

1. Merck. Merck Receives 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. Press Release. Aug. 26, 2024.
2. Hoeper, M. M.; Badesch, D. B.; Ghofrani, H. A.; et al. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N. Engl. J. Med. 2023, 388 (16) 1478–1490. DOI: 10.1056/NEJMoa2213558