FDA Clears Merck's Therapy for Rare, Fatal Lung Disease
The US Food and Drug Administration (FDA) has given its approval to Merck's new drug, sotatercept, for the treatment of pulmonary arterial hypertension (PAH), a rare and severe lung disease characterized by high blood pressure in the arteries of the lungs. The drug, which will be sold under the brand name Winrevair, is considered a significant medical advancement for PAH, which can lead to heart failure and has been described by doctors as a 'ticking time bomb'. Without treatment, PAH patients have a life expectancy of roughly two to three years post-diagnosis, although existing treatments can extend this period.
Winrevair is designed to bind and neutralize excess activin proteins involved in PAH, potentially altering the disease's underlying biology. The FDA's approval was based on clinical trial results, including the drug's ability to improve patients' walking distance in a six-minute walk test and a reduction in the risk of the disease worsening. The treatment is to be administered via injection every three weeks.
The drug's market availability is set to begin by the end of April in select specialty pharmacies in the United States. With a price tag of $14,000 per vial, the annual cost could reach approximately $242,000; however, Merck has announced a patient assistance program to help eligible patients manage out-of-pocket costs and copays. This approval is particularly significant for Merck as it looks to bolster its portfolio ahead of its top-selling cancer immunotherapy, Keytruda, losing market exclusivity in 2028. Analysts forecast that Winrevair could achieve global annual sales of around $5 billion by 2030.
