Sage Therapeutics Gets FDA Orphan Designation for SAGE-718 in Huntington's

By Colin Kellaher

Sage Therapeutics has won U.S. Food and Drug Administration orphan-drug designation for SAGE-718 for the treatment of the brain disorder Huntington's disease.

The Cambridge, Mass., biopharmaceutical company on Wednesday said it is advancing a clinical program for SAGE-718 with placebo-controlled Phase 2 studies across multiple disease areas, including its potential lead indication, cognitive impairment associated with Huntington's.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

The FDA previously granted fast-track designation to SAGE-718 for Huntington's.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

October 18, 2023 06:55 ET (10:55 GMT)

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