Shares in Biogen Idec were given a little nudge as investors welcomed news that regulatory submissions for its multiple sclerosis drug BG-12 have been accepted on both sides of the pond.
Both the US Food and Drug Administration and the European Medicines Agency have agreed to review Biogen’s applications to market BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of MS.
The submissions were based on data from two Phase III trials involving more than 2,600 patients which sparked some excitement amongst field experts.
Top-line data from the Phase III CONFIRM trial, which assessed the drug in patients with relapsing-remitting MS, showed that, when taken twice a day, 240mg of BG-12 cut the annualised relapse rate (ARR) by 44% after two years compared to placebo, and by 51% if taken three times a day.
By comparison, Teva’s blockbuster subcutaneous daily injection Copaxone (glatiramer acetate) was shown to reduce the ARR by 29% compared with placebo at two years, the firm said.
Another Phase III trial, DEFINE, showed that BG-12 significantly reduced the risk of relapse at two years by 49% and 50% at the twice- and three-times daily doses, respectively, versus the control group, again demonstrating its seemingly powerful efficacy.
If the drug does makes it onto pharmacy shelves it will significantly expand Biogen’s MS portfolio, which already houses the injectable blockbusters Avonex (interferon beta-1a) and Tysabri (natalizumab), and will compete for market share with Novartis’ Gilenya (fingolimod), the only MS pill currently on the market.
