CHMP Recommends Merck's Pulmonary Hypertension Drug

Merck & Co, known as MSD outside the US and Canada, has received an endorsement from the European Medicines Agency's human medicines committee for its pulmonary arterial hypertension (PAH) treatment for adults. The Committee for Medicinal Products for Human Use (CHMP) has advised that Winrevair (sotatercept), in combination with other PAH treatments, be approved to enhance exercise capacity in patients classified as World Health Organization functional classes two to three.

Currently, about 30,000 people in the EU suffer from PAH, a rare and progressive condition characterized by the thickening and narrowing of blood vessels in the lungs. This condition obstructs blood flow through the lungs, increasing blood pressure and placing a significant strain on the heart.

Winrevair is administered as a single injection once every three weeks. It functions by improving the balance between pro-proliferative and anti-proliferative signalling, which helps modulate vascular proliferation implicated in PAH. The CHMP's recommendation is backed by positive data from the late-stage STELLAR trial. This trial compared Winrevair to a placebo, both administered alongside standard care therapies in adult PAH patients.

The trial results demonstrated that adding Winrevair to the background therapy resulted in a statistically significant and clinically meaningful improvement in the primary endpoint of six-minute walk distance. It also showed positive outcomes in several secondary measures, including reducing the risk of death from any cause or PAH clinical worsening events.

Dr. Joerg Koglin, senior vice president and head of general medicine at Merck Research Laboratories, stated, "There is still a significant need for new therapies for PAH patients. This positive opinion marks the first step toward expanding access to our first-in-class activin signalling inhibitor therapy, Winrevair, for eligible adults with PAH in Europe."

The European Commission will now review the recommendation, with a final decision from the regulator expected in the third quarter of this year.

Additionally, Merck recently received approval from the US Food and Drug Administration for its adult-specific 21-valent pneumococcal conjugate vaccine. Capvaxive is now authorized to prevent invasive pneumococcal disease and pneumococcal pneumonia in individuals aged 18 years and older.