An Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Eteplirsen in Patients With Advanced Stage Duchenne Muscular Dystrophy
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 06 Oct 2017
At a glance
- Drugs Eteplirsen (Primary)
- Indications Duchenne muscular dystrophy
- Focus Adverse reactions; Registrational
- Sponsors Sarepta Therapeutics
- 03 Oct 2017 Planned End Date changed from 1 Sep 2017 to 1 Dec 2017.
- 19 Sep 2016 According to CureDuchenne Ventures media release, eteplirsen received accelerated approval from the Food and Drug Administration to treat Duchenne muscular dystrophy.
- 25 May 2016 According to a Sarepta Therapeutics media release, the US FDA has informed the company that they will not be able to complete the review of eteplirsen NDA by the Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016.