Biogen Idec Inc. BIIB said new data from studies evaluating its experimental multiple-sclerosis pill BG-12 further supports its effectiveness and safety in people with relapsing-remitting multiple sclerosis.
Most treatments for the chronic, inflammatory and potentially disabling disease are delivered by needle, but BG-12, or dimethyl fumarate, is an oral drug that will likely be taken twice daily. The drug is currently under review with U.S. and European regulators and could be approved early next year.
Biogen said Friday pooled data from the Phase 3 Define and Confirm studies showed statistically significant and clinically relevant reductions of multiple sclerosis relapses and progression of disability. The studies also found reductions in magnetic resonance imaging measures of disease activity.
In addition, interim safety data from a Phase 3 extension study indicated continued exposure to BG-12 didn't result in any new or worsening safety signals and were consistent with previous studies.
"These data provide additional insight into the positive efficacy and safety results from our Phase 3 studies, showing there is a consistent beneficial effect with dimethyl fumarate in reducing MS relapses, brain lesions and disability," said Alfred Sandrock, senior vice president of development sciences and chief medical officer. "If approved, dimethyl fumarate may provide a broad range of MS patients with an effective therapy that offers the ease of oral administration and an acceptable tolerability profile."... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1679