Acceleron receives FDA fast track designation for ACE-083 in Charcot-Marie-Tooth disease

Acceleron Pharma

28 November 2018 - Acceleron Pharma today announced that the United States FDA has granted fast track designation to ACE-083, the Company’s locally-acting “Myostatin+” muscle agent, for the treatment of patients with Charcot-Marie-Tooth disease.

ACE-083 is currently being evaluated in two Phase 2 trials: one in CMT and one in facioscapulohumeral muscular dystrophy (FSHD). Preliminary results from Part 2 of the trials are expected by year end 2019 for CMT and in the second half of 2019 for FSHD. Earlier this year, the FDA granted Fast Track and Orphan Drug designations for ACE-083 for the treatment of patients with FSHD.

Read Acceleron Pharma press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track