Posted by Michael Wonder on 26 Aug 2020
Sarepta Therapeutics announces FDA acceptance of casimersen (SRP-4045) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 45
25 August 2020 - Received FDA's conditional approval of Amondys 45 as brand name for casimersen.
Sarepta Therapeutics today announced the U.S. FDA has accepted the Company’s new drug application seeking accelerated approval for casimersen (SRP-4045) and provided a regulatory action date of 25 February 2021.
The FDA has indicated it does not currently plan to hold an advisory committee to discuss the application.
