Merck, known as MSD outside the US and Canada, said that the European Commission (EC) has approved Winrevair (sotatercept) for treating pulmonary arterial hypertension (PAH) in adult patients with World Health Organization (WHO) Functional Class (FC) 2 to 3.
The approval for Winrevair is in combination with other PAH therapies.
Winrevair, the first activin signalling inhibitor for PAH, is now approved across all 27 European Union (EU) member states, as well as in Iceland, Liechtenstein, and Norway.
The therapy improves exercise capacity by restoring the balance between pro- and anti-proliferative signalling, which regulates vascular cell proliferation associated with PAH.
Merck added sotatercept to its portfolio through the $11.5bn acquisition of Acceleron Pharma in 2021.
Previously, sotatercept received Priority Medicines (PRIME) and orphan designations from the European Medical Agency (EMA) for treating PAH.
In March 2024, the US Food and Drug Administration (FDA) approved Winrevair in the US for adults with PAH (WHO Group 1). The approval aims to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.
The latest approval follows the positive opinion from the EU’s Committee for Medicinal Products for Human Use (CHMP) in June.
Merck Research Laboratories global clinical development general medicine senior vice president and head Joerg Koglin said: “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.”
The EC approval is based on the global, double-blind, placebo-controlled, multicentre, parallel-group Phase 3 STELLAR trial.
The trial compared Winrevair to placebo in combination with standard care therapies in 323 adult patients with PAH (WHO Group 1, FC 2, or 3).
The primary endpoint was the change in six-minute walk distance from baseline at Week 24.
According to findings, sotatercept showed a statistically significant and clinically meaningful improvement, increasing the distance by 40.8 meters compared to the placebo.
Additionally, Winrevair enhanced several secondary outcomes, including reducing the risk of death or clinical worsening.
A post hoc analysis revealed an 82% reduction in the risk of death or clinical worsening with the therapy compared to background therapy alone.
