The Food and Drug Administration granted Merck priority review for its hypertension treatment sotatercept, following the results from the Phase 3 STELLAR trial, the company announced Thursday. 

Sotatercept is a novel investigational activin signaling inhibitor targeting pulmonary arterial hypertension (PAH), a rare and progressive disease that causes the narrowing of blood vessels in the lungs. 

Symptoms include fatigue, shortness of breath, dizziness, chest pain and heart palpitations.

The STELLAR trial results showed that patients with PAH saw greater improvement in their exercise capacity when taking sotatercept, compared to placebo.

The FDA has set a date in March 2024 for the review of sotatercept.

Dr. Joerg Koglin, SVP of global clinical development at Merck Research Laboratories, noted in a statement that the FDA’s acceptance of the biologics license application (BLA) for sotatercept was an “exciting milestone” in the princess of bringing the novel activin signaling inhibitor to patients.

“Despite advances in the treatment of PAH over the last two decades, there is still a significant need to improve outcomes for patients,” Koglin added. “Based on the profound improvements across primary and secondary outcome measures in the Phase 3 STELLAR trial, we believe sotatercept has the potential to transform the treatment of patients with PAH.”

Merck’s involvement with sotatercept dates back to 2021, when the pharma giant snapped it up in an $11.5 billion acquisition from Acceleron Pharma. 

At the time, Merck stated that the late-stage candidate would “complement and strengthen” its growing cardiovascular pipeline and estimated PAH would be a $7.5 billion market by 2026.

Picking up sotatercept is part of Merck’s overall strategy to offset the losses associated with its blockbuster drug Keytruda’s loss of exclusivity in 2028.

The news also comes on the heels of the FDA giving priority review to Merck’s Keytruda combination therapy, with concurrent chemoradiotherapy, for cervical cancer. 

That decision was based on Merck’s KEYNOTE-A18 trial, which showed the combination therapy was beneficial for patients with high-risk locally advanced cervical cancer.

Still, Merck’s efforts to expand Keytruda’s reach further with other combination therapies hasn’t been as smooth. Its Keytruda-Lenvima combination therapy, done with Eisai, has experienced several setbacks in trials this year across various cancers, including melanoma and lung cancer.