Orchard Therapeutics announces filing, validation of MAA by EMA for OTL-200
Orchard Therapeutics announced that the European Medicines Agency has validated the company's Marketing Authorization Application for OTL-200, an ex vivo, autologous, hematopoietic stem cell-based gene therapy that has been developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy in Milan, Italy, for the treatment of metachromatic leukodystrophy. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Orchard previously announced in November 2019 that the EMA had granted accelerated assessment for OTL-200. Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the MAA is filed and validated, not counting clock stops when applicants are requested to provide additional information.