Initiation of rolling submission for BLA of OTL 200 for metachromatic leukodystrophy to FDA.- Orchard Therapeutics
Orchard Therapeutics held a productive pre-BLA meeting with the FDA which led to the initiation of a rolling BLA for OTL 200 for the treatment of early-onset metachromatic leukodystrophy (MLD).
OTL 200 is approved as Libmeldy (atidarsagene autotemcel) by the European Commission (EC) and Medicines and Healthcare products Regulatory Agency (MHRA). Orchard expects to complete the OTL 200 rolling submission in mid-2023 and has requested priority review, which if granted would put the company on track for a potential U.S. approval in the first half of 2024.
Four patients have either received treatment or are currently undergoing treatment with Libmeldy so far in 2023, including the first patient identified via an MLD newborn screening study. Additional patients have been identified, referred, and are also expected to be treated in the second half of the year..
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