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Orphan Designation for Acceleron’s ACE-083
07/12/2018
 

FDA has granted Acceleron Pharma an orphan drug designation for ACE-083, the company’s locally acting myostatin+ muscle agent, for treating patients with facioscapulohumeral muscular dystrophy (FSHD). The designation was based on positive preliminary data from an ongoing Phase 2 trial in patients with FSHD, according to the company. In May, the agency granted the therapy fast track status. ACE-083 is also currently being evaluated in Charcot-Marie-Tooth disease.


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