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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER