Scholar Rock says FDA grants fast track status for apitegromab in FSHD
SRRK•FDA grants Fast Track designation for apitegromab
Scholar Rock said the FDA granted Fast Track designation for apitegromab in facioscapulohumeral muscular dystrophy (FSHD), adding to the program’s Orphan Drug status.
Participant dosing has started in the Phase 2 FORGE trial, which is testing 10 mg/kg intravenous apitegromab every four weeks for 52 weeks.
