Merck & Co’s – known as MSD outside of the US and Canada – pulmonary arterial hypertension (PAH) therapy has been granted approval by the European Commission (EC).
Winrevair (sotatercept) has been authorised for use in combination with other PAH therapies to improve exercise capacity in adults with World Health Organization (WHO) functional classes two to three.
About 30,000 people in the EU are living with PAH, a progressive disorder in which the blood vessels in the lungs thicken and narrow. This blocks the blood flow through the lungs, which raises blood pressure and results in a significant strain on the heart.
Merck’s Winrevair, which is administered as a single injection once every three weeks, is now the first and only activin signalling inhibitor therapy for PAH approved in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the phase 3 STELLAR trial, which compared Winrevair to placebo, both taken alongside background standard of care therapies in adult patients with PAH.
The Winrevair combination led to a statistically significant and clinically meaningful improvement in the study’s primary endpoint of six-minute walk distance, and on multiple secondary outcome measures, including reduction in the risk of death or clinical worsening.
Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories, described the approval as “an important step” for PAH patients.
“Winrevair is the first therapy targeting the activin signalling 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,” Koglin added.
The authorisation comes five months after Winrevair was approved by the US Food and Drug Administration, also to treat PAH in adults.
Merck gained access to the drug in 2021 through its $11.5bn acquisition of Acceleron Pharma.
Rob Davis, current chairman and chief executive officer, Merck, said when the deal was first announced: “Acceleron’s innovative research has yielded an exciting late-stage candidate that complements and strengthens our growing cardiovascular portfolio and pipeline and holds the potential to build upon Merck’s… legacy in cardiovascular disease.”