Merck, known as MSD outside of the United States and Canada, has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its new drug Winrevair (sotatercept). This recommendation is for the treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, aimed at improving exercise capacity when used in combination with other PAH therapies.
Winrevair, which has already been granted Priority Medicines (PRIME) and orphan drug designation by the EMA for PAH treatment, is now awaiting review by the European Commission (EC). A decision on its marketing authorization in the EU, Iceland, Liechtenstein, and Norway is anticipated in the third quarter of 2024.
PAH is a rare and debilitating disease, characterized by high blood pressure in the lungs’ arteries, which can lead to heart failure and severely limit physical activity. Merck’s senior vice president and head of global clinical development, Dr. Joerg Koglin, emphasized the urgent need for new therapies in PAH and expressed optimism about expanding access to Winrevair in Europe following the CHMP’s endorsement.
Winrevair works by inhibiting activin signalling, a pathway believed to modulate vascular proliferation in PAH. Its effectiveness was demonstrated in the Phase 3 STELLAR trial, where it showed significant improvements in the primary endpoint of 6-minute walk distance compared to background therapy alone. These findings were published in The New England Journal of Medicine.
Dr. Marius Hoeper from Hannover Medical School in Germany highlighted the potential of Winrevair to address the vascular abnormalities underlying PAH, based on its clinical benefits observed in the STELLAR study. He noted that Winrevair represents a novel treatment option targeting a new pathway in PAH management.
Following FDA approval in March 2024 for PAH treatment in the United States, Winrevair is now poised for potential approval in Europe, marking a significant milestone in expanding treatment options for this challenging condition.
PAH affects approximately 40,000 people in the US and 30,000 people in the EU, underscoring the critical need for effective therapies to manage this life-threatening condition. The mortality rate for PAH patients is notably high, highlighting the urgency of advancing treatments that can improve outcomes and quality of life for those affected.
In conclusion, Merck’s Winrevair represents a promising advancement in the treatment landscape for PAH, pending final approval by the European Commission later this year.