Posted by Michael Wonder on 02 Dec 2019
Orchard Therapeutics announces the filing and validation of marketing authorisation application by EMA for OTL-200 for the treatment of metachromatic leukodystrophy
2 December 2019 - Application Being Evaluated Under Accelerated Assessment.
Orchard Therapeutics today announced that the EMA has validated the company’s marketing authorisation application for OTL-200, an ex vivo, autologous, haematopoietic 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 application 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 application is filed and validated, not counting clock stops when applicants are requested to provide additional information.
