Orchard Therapeutics completes submission of BLA for OTL-200 in MLD to U.S. FDA

Orchard Therapeutics announced several business accomplishments along with its financial results for the quarter ended June 30, 2023. “With the completion of the rolling BLA submission for OTL-200 to the FDA, we are now one significant step closer to bringing this important therapy to families in the U.S. affected by MLD who currently have no treatment options beyond supportive care,” said Bobby Gaspar, M.D., Ph.D., chief executive officer. “We look forward to working with the agency throughout the filing and review process and expect to hear from the FDA regarding acceptance of the BLA in the third quarter of this year.” The company has completed the rolling submission of its Biologics License Application, BLA, to the U.S. Food and Drug Administration, FDA, for OTL-200, in children with early-onset metachromatic leukodystrophy, MLD. OTL-200 previously received both Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA. Orchard Therapeutics has requested priority review, which if granted, would put OTL-200 on track for a potential U.S. approval in the first half of 2024.