Posted by Michael Wonder on 08 Apr 2020
Acceleron receives FDA breakthrough therapy designation for sotatercept in pulmonary arterial hypertension
8 April 2020 - Sotatercept granted first FDA breakthrough therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012.
Acceleron Pharma today announced that the United States FDA has granted Breakthrough Therapy designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH) (World Health Organization Group 1).
Sotatercept is an investigational agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR-II signalling, which is a key molecular driver of PAH.
