Merck’s Experimental Therapy for Progressive Blood Vessel Disorder to Receive Priority Review by FDA

Merck, a leading pharmaceutical company, announced on Thursday that its experimental therapy for a type of progressive blood vessel disorder will undergo a priority review by the U.S. Food and Drug Administration (FDA). The therapy, called sotatercept, was acquired by Merck through its acquisition of Acceleron Pharma for $11.5 billion in 2021.

The FDA has set a target action date of March 26, 2024, for the review process. If approved, sotatercept will provide Merck with a new revenue stream as its blockbuster cancer immunotherapy, Keytruda, approaches loss of market exclusivity in 2028.

Merck’s application for sotatercept is based on data from a late-stage study, which demonstrated that the therapy, when combined with a background treatment, helped patients with pulmonary arterial hypertension (PAH) to walk an additional 40.8 meters in six minutes. This could potentially make sotatercept the first treatment of its class, targeting activins, a type of protein associated with higher levels of follicle-stimulating hormone linked to the disease.

Analyst Chris Schott from J.P. Morgan estimated that sotatercept could reach peak sales of $3 billion to $4 billion. Merck expects the PAH market to be worth approximately $7.5 billion by 2026, as stated during the announcement of the Acceleron deal.

PAH is a rare and progressive disorder characterized by high blood pressure in the arteries of the lungs. In the U.S., around 500-1000 new cases of PAH are diagnosed each year, according to government data.

Merck’s pursuit of sotatercept highlights its commitment to developing innovative therapies to address unmet medical needs. The priority review by the FDA underscores the potential significance of this therapy in treating patients with PAH. If approved, sotatercept could provide hope for those affected by this debilitating condition and further solidify Merck’s position in the pharmaceutical industry.