Sage Therapeutics Gets FDA Orphan Designation for SAGE-718 in Huntington's
2023年10月18日 - 8:10PM
Dow Jones News
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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