Europe – Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension

Winrevair received support through PRIority Medicines (PRIME) scheme due to its potential to bring a major therapeutic advantage over existing therapies

EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity.

Pulmonary arterial hypertension is a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries in the lungs. Many patients experience breathing difficulty that limits their physical activity. Despite approved therapies, long-term prognosis remains poor: it is estimated that around 50% of patients will die within five to seven years after diagnosis…