US biotech firm Biogen Idec (Nadaq: BIIB) has submitted its orally-active drug for relapsing-remitting multiple sclerosis BG-12 with the Food and Drug Administration in the USA, with a European Union application due to follow in the coming days.
If approved, BG-12 (dimethyl fumarate) will join a select group of orally-active MS drugs that are trying to make headway in a market dominated by injectable therapies based on beta interferon.
The regulatory submission was based on two Phase III studies - DEFINE and CONFIRM - which showed that Biogen Idec's drug achieved significant reductions in MS disease activity with favourable safety and tolerability.
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