Sage receives Orphan Drug Designation for SAGE-718 from FDA

Sage Therapeutics announced the FDA granted Orphan Drug Designation, or ODD, to SAGE-718 for the treatment of Huntington’s disease, or HD. SAGE-718 is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction. Multiple clinical studies are ongoing with SAGE-718 across several disease areas, including two placebo-controlled Phase 2 studies and a Phase 3 open-label safety study in the potential lead indication of HD-related cognitive impairment, as well as Phase 2 placebo-controlled studies in mild cognitive impairment, MCI, associated with Parkinson’s disease, or PD, and MCI and mild dementia due to Alzheimer’s disease, or AD. SAGE-718 previously received Fast Track Designation from the FDA for HD, and orphan drug designation for HD by the European Medicines Agency.