Acceleron Pharma's investigational molecule sotatercept for the treatment of pulmonary arterial hypertension (PAH), has been granted the designation of breakthrough therapy by the U.S. Food and Drug Administration (FDA).
Medications that have the potential to provide significant advantages over currently available options are given breakthrough designation. This designation is intended to accelerate the development, review, and approval of treatments for serious or life-threatening conditions. It follows sotatercept’s inclusion in the FDA’s orphan drug programme in 2019 which provides a seven-year period of marketing exclusivity if the treatment receives regulatory approval.
Sotatercept is an investigational compound that works to counteract the abnormal bone morphogenic protein (BMP) signalling in the lungs, believed to be a critical driver of the vascular remodelling processes that contribute to PAH development and progression.
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