Biogen Idec (BIIB) said detailed positive data from CONFIRM, the second Phase 3 trial of oral BG-12, or dimethyl fumarate, in people with relapsing-remitting multiple sclerosis, or RRMS, will be presented in three platform presentations at the 64th Annual Meeting of the American Academy of Neurology in New Orleans.
In CONFIRM, BG-12 demonstrated efficacy across a variety of clinical and radiological outcome measures, as well as favorable safety and tolerability profiles. These data, along with results from BG-12's first Phase 3 study, DEFINE, were included in regulatory applications that were submitted to U.S. and EU regulatory agencies early this year.
Earlier this year, Biogen Idec announced that it had submitted a New Drug Application to the U.S. Food and Drug Administration for marketing approval of BG-12 in the United States and a Marketing Authorisation Application to the European Medicines Agency, or EMA, for review in the European Union. The EMA has validated Biogen Idec's Marketing Authorisation Application and is reviewing the BG-12 data package. Biogen Idec is awaiting formal acceptance of its NDA for review by the FDA.
by RTT Staff Writer
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