Orchard Therapeutics: FDA Grants Fast Track Designation To OTL-203

(RTTNews) - Orchard Therapeutics (ORTX) announced the FDA has granted Fast Track designation to OTL-203, an investigational hematopoietic stem cell gene therapy being developed for the potential treatment of the Hurler subtype of mucopolysaccharidosis type I. OTL-203 has previously received Rare Pediatric Disease and priority medicines designations from the FDA and European Medicines Agency, respectively.

"We look forward to initiating our global registrational trial in December to evaluate the efficacy and safety of OTL-203 compared to allogeneic hematopoietic stem cell transplant," Leslie Meltzer, chief medical officer, said.

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