Background Analysis: US FDA Advisory Committee to Review BioMarin’s Drisapersen for Duchenne Muscular Dystrophy – NOV 24, 2015 (PCNS)
The US FDA has scheduled a Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting for Tuesday, November 24, 2015 to discuss new drug application (NDA) 20631 for the treatment of patients with Duchenne muscular dystrophy amenable to exon 51 skipping as determined by genetic testing.
Drisapersen was acquired by BioMarin from Prosensa, after GlaxoSmithKline discontinued co-development of the drug with Prosensa.