Acceleron's PAH drug gets the FDA's red carpet treatment with breakthrough status
Days after scoring expanded approval for its potential blockbuster anemia therapy, Acceleron has the FDA fawning over its experimental drug sotatercept — with the US regulator granting the potential pulmonary arterial hypertension drug breakthrough status.
Sotatercept, which was granted orphan drug designation by the US regulator last year, is engineered to restore BMPR-II signaling, a key driver of the disease, versus existing PAH therapies that are designed to dilate the pulmonary arteries and reduce blood pressure.
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