(Reuters) - Biogen Idec Inc said on Friday that a closer look at data from two late-stage studies supported previous findings that its high-profile multiple sclerosis pill BG-12 significantly reduced relapses and progression of disability related to MS.
The company said its confidence was bolstered by analyzing combined data from the two Phase 3 studies, called DEFINE and CONFIRM, and suggested that it could win U.S. marketing approval for BG-12 by the end of the year.
Approval has been expected for this year or early next year.
Biogen already markets two MS drugs, but BG-12 would be one of the first oral drugs to reach the market and compete with Novartis AG’s Gilenya. It is ultimately expected, if approved, to be one of the leading MS drugs on the market.
“We are optimistic we could have approval in the U.S. by the end of this year,” Alfred Sandrock, chief medical officer of Biogen, said during a press conference at the European Committee for the Treatment and Research of Multiple Sclerosis conference in Lyon, France.
Biogen is already one of the world’s biggest players in the market for drugs to treat multiple sclerosis, a progressive neurological disease that can lead to paralysis. It is caused by an overactive immune system that destroys the myelin sheath that protects nerves.
The company’s currently marketed products are injectable Avonex and newer Tysabri, which is given by infusion.
When asked if BG-12 will wrest sales away from Avonex and Tysabri, Sandrock said, “There will be some people who will move to BG-12 from all drugs, but I don’t think it will a complete shift. There will be a place for other drugs.”
Biogen’s drugs also compete with Rebif, sold by the Merck Serono division of German drugmaker Merck KGaA, Teva Pharmaceutical Industries Ltd’s Copaxone and Bayer AG’s Betaseron.
Reporting By Caroline Humer; Additional reporting by Elena Berton in Lyon, France; Editing by Steve Orlofsky