Posted by Michael Wonder on 31 Oct 2024
PTC Therapeutics announces FDA acceptance of Translarna NDA resubmission
30 October 2024 - PTC Therapeutics announced today the US FDA has accepted for review the resubmission of the new drug application for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy.
The new drug application resubmission is based on the findings of significant benefit demonstrated in the ITT population (N=359) of the global placebo controlled trial Study 041.
