An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Drisapersen in US and Canadian Subjects With Duchenne Muscular Dystrophy
Phase of Trial: Phase III
Latest Information Update: 03 Nov 2016
At a glance
- Drugs Drisapersen (Primary)
- Indications Duchenne muscular dystrophy
- Focus Adverse reactions; Registrational
- Sponsors BioMarin Nederland
- 31 May 2016 According to a BioMarin media release, the company has withdrawn its MAA for drisapersen (Kyndrisa) from the EMA following discussions at the May 2016 CHMP meeting. Those discussions clearly indicated that the CHMP intended to issue a negative opinion. BioMarin intends to discontinue clinical and regulatory development of Kyndrisa as well as the three other first-generation follow-on products, BMN 044, BMN 045 and BMN 053.
- 31 May 2016 Status changed from active, no longer recruiting to discontinued, according to a BioMarin media release.
- 28 Feb 2016 Planned End Date changed from 1 Apr 2016 to 1 Jun 2017 as per ClinicalTrials.gov record.