Applied Therapeutics Gets FDA Fast-Track Designation for AT-007 in Galactosemia
17 Giugno 2021 - 1:32PM
Dow Jones News
By Colin Kellaher
Applied Therapeutics Inc. on Thursday said the U.S. Food and
Drug Administration granted fast-track designation to AT-007 for
the treatment of galactosemia, a rare inherited disorder that
hinders the body's ability to process and produce energy from a
sugar called galactose.
The New York clinical-stage biopharmaceutical company said there
are currently no drugs approved for galactosemia, adding that it
plans to file for accelerated FDA approval of AT-007 for the
treatment of the disease in the third quarter.
The FDA's fast-track program is designed to facilitate the
development and expedite the review of treatments for serious or
potentially life-threatening illnesses with high unmet medical
needs.
The agency previously granted orphan-drug and
rare-pediatric-disease designation to AT-007 for galactosemia.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 17, 2021 07:29 ET (11:29 GMT)
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