By Colin Kellaher

 

MeiraGTx Holdings PLC on Tuesday said the U.S. Food and Drug Administration granted fast-track designation to its AAV-CNGA3 gene-therapy product candidate to treat the retinal disease achromatopsia caused by mutations in the CNGA3 gene.

The New York clinical-stage biotechnology company said it is currently conducting an open-label, dose-escalation Phase 1/2 clinical trial of AAV-CNGA3, which it is developing as part of a collaboration with Johnson & Johnson's Janssen Pharmaceuticals Inc. unit aimed at the treatment of inherited retinal diseases.

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 designation to AAV-CNGA3 and has designated it as a drug for a rare pediatric disease.

 

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

 

(END) Dow Jones Newswires

January 26, 2021 11:13 ET (16:13 GMT)

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