FDA sets June de­ci­sion dead­line for po­ten­tial full ap­proval, la­bel ex­pan­sion of Sarep­ta’s Duchenne gene ther­a­py

Sarep­ta Ther­a­peu­tics could soon notch an­oth­er reg­u­la­to­ry win.

De­spite the com­pa­ny and its Duchenne gene ther­a­py get­ting dogged by de­bate, and then a failed con­fir­ma­to­ry study, the treat­ment ap­pears head­ed for a la­bel ex­pan­sion that would broad­en its use be­yond boys ages 4 and 5.

On Fri­day, the com­pa­ny an­nounced that the FDA set a June 21 dead­line to make de­ci­sions on ex­pand­ing Ele­v­idys’ la­bel and con­vert­ing its ac­cel­er­at­ed ap­proval in­to a full one. And Sarep­ta won’t have to face an FDA ad­vi­so­ry com­mit­tee for the treat­ment, a pos­i­tive sig­nal from the agency that it won’t ask a pub­lic pan­el of out­side ex­perts for in­put.

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