MSD gains European approval for pulmonary arterial hypertension treatment

MSD's Winrevair (sotatercept) has been approved by the European Commission (EC) for treating adults with functional class II or III pulmonary arterial hypertension (PAH). PAH is a severe disorder caused by high blood pressure in the lungs. This approval allows Winrevair to be used as a combination therapy for these patients, who are classified based on the World Health Organization (WHO) functional classes.

The EC granted approval after reviewing data from the STELLAR Phase III study (NCT04576988), which involved 323 adult participants with functional class II or III PAH. This study, pivotal to the approval, provided robust evidence supporting the efficacy and safety of Winrevair. The therapy is administered subcutaneously, offering a new treatment option for patients in Europe.

Winrevair had previously received approval from the US Food and Drug Administration (FDA) in March 2024 for the same patient group. According to GlobalData’s consensus forecasts, Winrevair is projected to achieve total sales of $6.3 billion by 2030, indicating strong market potential for this treatment. 

Interestingly, the approval of Winrevair followed closely after the FDA's approval of Johnson & Johnson’s (J&J) Opsynvi (macitentan + tadalafil) for adult patients with WHO Group 1 and functional classes II and III PAH. This highlights a growing focus on developing effective treatments for PAH, a condition that significantly impacts patients' quality of life.

The STELLAR study results, published in the New England Journal of Medicine, showed that Winrevair significantly improved exercise capacity in PAH patients. Participants demonstrated a median increase in the 6-minute walk distance (6MWD) from baseline by 34.4 meters, compared to a mere 1.0 meter with placebo at 24 weeks. This improvement in 6MWD was the primary efficacy endpoint of the study. While the incidence of adverse events was similar between the treatment and placebo groups, those receiving Winrevair reported higher instances of epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.

Winrevair is a first-in-class activin signaling inhibitor, designed to enhance exercise capacity in PAH patients by binding to several TGF beta superfamily ligands and blocking their signals. This mechanism of action targets the underlying pathophysiology of PAH, representing a novel therapeutic approach. Dr. Joerg Koglin, MSD senior VP and head of general medicine at Merck Research Laboratories, described the approval as an essential milestone for PAH patients, emphasizing MSD's commitment to addressing unmet medical needs in PAH management.

PAH is a rare but serious blood vessel disorder characterized by the narrowing of small blood vessels in the lungs, leading to elevated pulmonary artery pressure. This condition can cause significant morbidity and mortality, underscoring the importance of innovative treatments like Winrevair.

Overall, the approval of Winrevair in Europe marks a significant advancement in PAH treatment, offering hope to patients and healthcare providers seeking more effective therapies to manage this debilitating disease.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!