Posted by Michael Wonder on 23 Dec 2023
Sarepta Therapeutics submits efficacy supplement to expand the Elevidys label to include Duchenne muscular dystrophy patients without restriction to age or ambulatory status
22 December 2023 - Sarepta has also submitted the EMBARK post-marketing requirement to the FDA seeking conversion of the Elevidys accelerated approval to traditional approval.
Sarepta Therapeutics today announced submission of an efficacy supplement to the biologics license application for Elevidys (delandistrogene moxeparvovec-rokl) to expand its labeled indication as follows “[Elevidys is indicated for] the treatment of Duchenne muscular dystrophy (DMD) patients with a confirmed mutation in the DMD gene.”
