Orchard Therapeutics completes submission of biologics license application for OTL-200 in MLD to US FDA

Orchard Therapeutics

3 August 2023 - Four MLD patients identified from ~150,000 newborns screened in prospective studies suggests significantly higher incidence than previously estimated in the medical literature.

The company has completed the rolling submission of its biologics license application to the US FDA for OTL-200, in children with early-onset metachromatic leukodystrophy.

Read Orchard Therapeutics press release

Michael Wonder

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Michael Wonder

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US , Dossier , Cellular therapy