Biogen Idec’s (NASDAQ:BIIB) new multiple sclerosis drug Tecfidera has been recommended for approval in Europe.

The European Medicines Agency’s Committee for Medicinal Products for Human use said today that the the drug, formerly known as BG-12, should be granted marketing authorization. The recommendation comes ahead of an expected U.S. Food and Drug Administration decision on the drug, which could come next week.

Weston, Mass.-based Biogen makes its MS drugs Avonex and Tysabri at its manufacturing plant in Research Triangle Park. Tecfidera will follow Novartis’ Gilenya to the market in the EU as an oral option for the treatment of MS. Because of its safety profile and efficacy, Biogen’s Tecfidera may generate $3.25 billion in annual revenue by 2017, based on the average analyst estimate compiled by Bloomberg.

Multiple sclerosis affects an estimated 2.1 million people worldwide, causing symptoms ranging from limb numbness to blindness and paralysis, according to the National Multiple Sclerosis Society. Other MS drugs, including Biogen’s, are given by injection or intravenous infusion, and patient anticipation for Tecfidera may drive it to capture as much as 20 percent of the MS market within a year, according to Eric Schmidt, a Cowen & Co. analyst.

“This will probably be the No. 1 drug in MS,” said Michael Yee, an analyst with RBC Capital Markets in San Francisco, in a March 19 telephone interview with Bloomberg. He recommends buying Biogen shares.

Stock Surge

Biogen’s stock has doubled since April 2011 when the company first reported positive data from a late-stage trial of Tecfidera. The results were better than analysts and investors had expected, and they were bolstered later that year with results from a second trial, dubbed Confirm.

The most common form of MS is relapsing-remitting, characterized by neurological attacks followed by periods of recovery. The studies together showed that Tecfidera reduced patients’ annual relapse rate by 49 percent when given either twice a day or three times a day, and cut the proportion of patients who relapsed by 43 percent at twice-daily dosing and 47 percent at three times daily compared with placebo.

Overall, side effects were similar across the placebo and treatment groups, with the most common adverse events associated with Tecfidera being flushing and gastrointestinal effects, the company said.

A decision on Tecfidera is due from the U.S. Food and Drug Administration by March 28. The drug was delayed by the FDA in October for three months without asking for additional studies. The agency said it needed more time to review the application, Biogen said.

Sanofi has an oral MS drug, Aubagio, that’s approved in the U.S. The EMA today also recommended that the Paris-based company be granted marketing authorization in the EU for Aubagio.

(Bloomberg News contributed to this report)