Mean lymphocyte counts decreased during the first year of BG-12 treatment and then plateaued, staying within normal limits throughout the entire treatment period. The incidence of hepatic and renal events was comparable among all study groups. The incidence of serious infections was low and balanced across the study groups, and there were no opportunistic infections. In CONFIRM, there were no malignancies in the BG-12 groups, one malignancy in the placebo group and four malignancies in the GA group.
“Results from CONFIRM are similar to what was observed in DEFINE, providing favorable safety data from these two substantial global studies,” said J. Theodore Phillips, M.D., Ph.D., program director of the Multiple Sclerosis Program at the Baylor Institute for Immunology Research, clinical professor of Neurology at the University of Texas Southwestern Medical Center, and investigator in the CONFIRM study. “The most common BG-12 side effects were flushing and GI events, which decreased substantially in incidence after the first month and resulted in a low incidence of discontinuations.”
These data will be presented in three platform presentations at the AAN annual meeting:
- Clinical Efficacy of BG-12 in Relapsing-Remitting Multiple Sclerosis (RRMS): Data from the Phase 3 CONFIRM Study (S01.003) will be presented by Dr. Robert J. Fox on Tuesday, April 24, 2012 from 1:30-1:45 p.m. CDT
- Effects of BG-12 on Magnetic Resonance Imaging (MRI) Endpoints in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Data from the Phase 3 CONFIRM Study (S11.001) will be presented by Dr. David Miller of the University College London’s Institute of Neurology, on Tuesday, April 24, 2012 from 3:00-3:15 p.m. CDT
- Safety and Tolerability of BG-12 in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Analyses from the CONFIRM Study (S41.005) will be presented by Dr. J. Theodore Phillips on Thursday, April 26, 2012 from 2:00-2:15 p.m. CDT
BG-12 Regulatory StatusEarlier this year, Biogen Idec announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of BG-12 in the United States and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for review in the European Union. The EMA has validated Biogen Idec’s MAA and is reviewing the BG-12 data package. Biogen Idec is awaiting formal acceptance of its NDA for review by the FDA.