Pfizer Gets FDA Fast-Track Designation for Duchenne Muscular Dystrophy Therapy
01 October 2020 - 9:29PM
Dow Jones News
By Colin Kellaher
Pfizer Inc. on Thursday said the U.S. Food and Drug
Administration granted fast-track designation to PF-06939926, its
investigational gene-therapy candidate in development to treat
Duchenne muscular dystrophy.
The New York drugmaker said it currently evaluating PF-06939926
to determine its safety and efficacy.
The FDA's fast-track program is designed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need.
Duchenne muscular dystrophy, a rare, fatal neuromuscular genetic
disease that occurs in roughly one in every 3,500 to 5,000 males,
is caused by a change or mutation in the gene that encodes
instructions for dystrophin, a protein found in muscle cells.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 01, 2020 07:14 ET (11:14 GMT)
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