Posted by Michael Wonder on 26 Jan 2021
MeiraGTx announces AAV-CNGA3 granted fast track designation by U.S. FDA for treatment of achromatopsia
26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy product candidate for the treatment of achromatopsia caused by mutations in the CNGA3 gene.
AAV-CNGA3 has already been granted orphan drug designation by the FDA and European Medicines Agency.
In addition, AAV-CNGA3 for the treatment of achromatopsia caused by mutations in the CNGA3 gene has been designated as a drug for a rare paediatric disease by the FDA.
