Biogen Idec (BIIB) Thursday announced that the U.S. Food and Drug Administration, or the FDA, has extended the initial PDUFA date for its review of the New Drug Application for the marketing approval of BG-12, the oral therapeutic candidate for the treatment of multiple sclerosis, or MS.
The company, engaged in the discovery and development of innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders, stated that the extension of the PDUFA date is needed to allow additional time for review of the application.
The company further stated that the FDA has not asked for additional studies.
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