MeiraGTx's AAV-CNGA3 Gets FDA Fast-Track Designation in Achromatopsia
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
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
January 26, 2021 11:13 ET (16:13 GMT)
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