FDA give go ahead for clinical trials in gene therapy for x-linked myotubular myopathy

Audentes Therapeutics today announce approval by the US FDA (Food and Drug Administration) for their application for gene therapy human clinical trials. The approval means they can initiate this Phase 1/2 study, and begin the process of enrolling patients. They are also applying to the European authorities – the EMA (European Medicines Agency) as this will be a multi-national study. (Applications to the EMA take longer)

To read Audentes Therapeutics’ announcement