The FDA designates Acceleron Pharma's (XLRN -0.2%) ACE-083 for Fast Track review for the treatment of facioscapulohumeral muscular dystrophy, a form of muscular dystrophy that affects the muscles of the face, scapula and upper arms.
Fast Track status shortens the review clock to six months from the standard 10 months.
Phase 2-stage ACE-083, based on a naturally occurring protein called follistatin, binds to (inhibits) certain proteins that negatively regulate muscle growth (activins and myostatin). The company says untreated muscles or other organs are unaffected thereby reducing the risk of unwanted systemic side effects.
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