FDA Grants Orphan Drug Designation For Sage Therapeutics' SAGE-718 To Treat Huntington's Disease

(RTTNews) - Sage Therapeutics, Inc. (SAGE) Wednesday said the Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to SAGE-718 for the treatment of Huntington's disease (HD).

Under the Orphan Drug Act, the FDA may provide grant funding towards clinical trial costs, tax advantages, FDA user-fee benefits, and the potential for seven years of market exclusivity in the United States for the drug in the orphan indication following drug approval by the FDA.

Multiple clinical trials are ongoing with SAGE-718 for cognitive disorders associated with NMDA receptor dysfunction, including HD, Parkinson's disease and Alzheimer's disease.

SAGE-718 had previously received Fast Track Designation from the FDA for HD, and orphan drug designation for HD by the European Medicines Agency.