Pfizer Gets FDA Fast-Track Designation for Duchenne Muscular Dystrophy Therapy

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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