FDA Schedules June Deadline for Potential Approval and Broader Usage of Sarepta's Duchenne Genetic Treatment

Despite controversies and a failed study, Sarepta's Duchenne gene therapy, Elevidys, may soon expand its use beyond the initial age group. The FDA has set June 21 this year as the deadline for this potential expansion and full approval decision, without requiring an advisory committee review. This development could significantly impact the rare disease gene therapy field, reflecting a shift in regulatory approaches.

CDMO Catalent has served as Sarepta’s main commercial manufacturing partner for Elevidys, and also supports other candidates in Sarepta’s pipeline. To meet the increasing demand for gene therapies, in 2021 Catalent announced a six-year program to spend $360-million expanding its Maryland facilities.

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