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MeiraGTx's AAV-RPGR for retinitis pigmentosa gets fast track designation

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The FDA has granted fast track designation to AAV-RPGR for the treatment of X-linked retinitis pigmentosa, MeiraGTx announced in a press release.

The fast track process will allow MeiraGTx to have early and frequent communication with the FDA through the development and review process and possibly facilitate faster drug approval, the release said.

AAV-RPGR, a gene therapy product candidate for the treatment of X-linked retinitis pigmentosa, has received orphan drug designation from the FDA and orphan medicinal product designation from the European Medicines Agency. It is designed to treat the most common form of X-linked retinitis pigmentosa caused by mutations in the RPGR gene, according to the release.

A phase 1/2 trial of the product candidate is currently ongoing.