Orchard Therapeutics: CHMP Adopts Positive Opinion For Libmeldy - Quick Facts

(RTTNews) - Orchard Therapeutics (ORTX) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending full, or standard, marketing authorization for Libmeldy, an investigational gene therapy for the treatment of metachromatic leukodystrophy. A final decision by the European Commission for Libmeldy is expected before the end of 2020.

Orchard Therapeutics noted that, if approved, Libmeldy would be the first commercial therapy and first gene therapy for eligible patients with early-onset Metachromatic Leukodystrophy.