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Acceleron hypertension drug gets US FDA breakthrough therapy tag

The U.S. Food and Drug Administration granted breakthrough therapy status to Acceleron Pharma Inc.'s hypertension drug sotatercept.

Sotatercept is a potential therapy for treating pulmonary arterial hypertension, or PAH, which is a chronic disorder characterized by high blood pressure in the arteries of the lungs for no apparent reason.

The FDA designation is meant to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition.

The Cambridge, Mass.-based biopharmaceutical company in January announced results from a phase 2 trial, dubbed Pulsar, which showed that sotatercept significantly reduced blood flow resistance in the blood vessels of the lungs in patients with PAH.

Sotatercept was given orphan drug status in the U.S. in 2019 for the same indication.