Posted by Michael Wonder on 19 Nov 2019
European Medicines Agency grants Orchard Therapeutics accelerated assessment of OTL-200 for patients with metachromatic leukodystrophy
18 November 2019 - Orchard Therapeutics today announced that the CHMP of the EMA has granted an accelerated assessment for OTL-200, a gene therapy in development for the treatment of metachromatic leukodystrophy in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.
The EMA awards an accelerated assessment to medicines that are expected to be of major public health interest, particularly in the area of therapeutic innovation. Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the marketing authorisation application is filed and validated, not counting clock stops when applicants are requested to provide additional information. The decision to grant accelerated assessment has no impact on the eventual CHMP and Committee for Advanced Therapies opinion on whether a marketing authorisation should be granted.
