Sarep­ta's gene ther­a­py to be man­u­fac­tured at Catal­ent plant with 'op­er­a­tional chal­lenges' this spring

Catal­ent, the con­tract man­u­fac­tur­er in the process of over­haul­ing its op­er­a­tions, is man­u­fac­tur­ing Sarep­ta Ther­a­peu­tics’ new­ly ap­proved gene ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy at one of its plants cit­ed for op­er­a­tional and pro­duc­tion chal­lenges.

The FDA on Thurs­day grant­ed ac­cel­er­at­ed ap­proval to Ele­v­idys, a one-time gene ther­a­py al­so known as SRP-9001 or de­landis­tro­gene mox­epar­vovec-rokl, in chil­dren who are 4 and 5 years old.

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