Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting

November 24, 2015

The FDA Advisory committee discusses new drug application (NDA) 206031, drisapersen solution for injection, sponsored by BioMarin Pharmaceutical Inc., for the treatment of patients with  with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping as determined by genetic testing.

From FDA Presentation, It Shares Possible Reasons to Conduct Post-hoc Analyses of a Failed Study

FDA Slide 23-Possible Reasons to Conduct Post-hoc Analyses of a Failed Study

The Duchenne Timeline

FDA Meeting Materials for NDA 206031 Drisapersen Solution for injection