Merck’s Sotatercept Hits Phase III Marks In Mid-Stage PAH Patients

Merck & Co., Inc. hit a key milestone in advancing its cardiovascular pipeline on 10 October, announcing a successful Phase III trial for sotatercept, a reverse-remodeling agent proposed to rebalance TGF-beta superfamily signaling, in mid-stage pulmonary arterial hypertension (PAH) patients. The pharma said it will move “with urgency” in speaking with regulators about an approval pathway for sotatercept.

In an interview, Merck chief medical officer Eliav Barr said the company feels that urgency because PAH care lacks for an approved therapy that addresses the underlying cause of the disease and because the disease has an estimated five-year mortality rate of 43%. Sotatercept is a key component of the company’s goal of eight new approvals and $10bn in revenue for its cardiovascular franchise by 2030, two years after US patent expiration for its current top-selling drug, the cancer checkpoint inhibitor Keytruda (pembrolizumab)