Briefing Summary: US FDA Posts Advisory Committee Materials for BioMarin’s Drisapersen for Duchenne Muscular Dystrophy – NOV 24, 2015 (PCNS)
The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, November 24, 2015 Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting. The Committee will discuss new drug application (NDA) 20631 by BioMarin Pharmaceutical, Inc. (BioMarin) for drisapersen solution for injection, for the treatment of patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping as determined by genetic testing.
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