Drug news
Sarepta to file eteplirsen at FDA for Duchenne Muscular Dystrophy in early 2014
Sarepta Therapeutics, Inc has announced it plans to submit a New Drug Application (NDA) to the FDA in the first half of 2014 for the approval of eteplirsen for the treatment of Duchenne Muscular Dystrophy (DMD). Eteplirsen is Sarepta's lead exon-skipping compound in development for the treatment of patients with DMD who have a genotype amenable to skipping of exon 51.
The decision to submit an NDA for eteplirsen in 2014 is based on productive interactions with the FDA in a meeting that occurred this week.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.