Biogen Idec Wins FDA Approval For Oral Multiple Sclerosis Drug

3/27/13Follow @xconomy

[Updated: 3/29/13, 1:40 pm ETBiogen Idec, already the world’s largest maker of multiple sclerosis drugs, has been eagerly awaiting the green light to start selling its next big thing—its first oral pill for MS. Today, the FDA gave that all-important go-ahead.

The Weston, MA-based biotech company (NASDAQ: BIIB) won clearance to sell dimethyl fumarate (Tecfidera) to treat adults with relapsed forms of multiple sclerosis, according to a statement today by the FDA.

The drug, formerly known as BG-12, is expected by many investors to become the top-selling product for the treatment of multiple sclerosis, a neurodegenerative disease that disables people over a number of years. The drug showed an ability, in a pair of clinical trials with more than 2,600 patients, that it could significantly reduce the number of disease flare-ups over a two-year period. Flushing and stomach problems like nausea, vomiting, and diarrhea were the most reported side effects, although they appeared to reduce over time, the FDA said.

“No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients,” said Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in an FDA statement. “Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.”

Multiple sclerosis has traditionally been treated with injectable drugs, including Biogen’s own interferon beta (Avonex) and natalizumab (Tysabri), but many patients have long sought the convenience of oral pills. Novartis’s fingolomid (Gilenya) was the first oral MS drug approved by the FDA in September 2010, but it has struggled in the marketplace because of its side effect profile. Biogen’s challenger should allay some of those safety concerns, analysts say.

Biogen Idec should see $252 million in product sales in 2013, $1.13 billion in 2014, and $2 billion in 2015, according to Thomas Wei, an analyst with Jefferies & Co., in a note to clients this week. The drug could generate $3.25 billion in annual sales for Biogen Idec by 2017, according to analyst estimates compiled by Bloomberg.

Wei’s estimate, written before the FDA approval, expected Biogen to set the price for the new drug at $56,380 per year, compared with the original price of $48,083 per year for the competing oral drug from Novartis.

Shares of the company climbed 3.2 percent today to close at $182.69.

The prescribing information for Tecfidera is “clean,” with no black-box warning about particularly dangerous side effects, or “onerous monitoring requirements,” said Mark Schoenebaum, an analyst with ISI Group, in a note to clients after the approval. Biogen hasn’t yet released the product’s price, but Schoenebaum said he expects it to be between $50,000 and $60,000 a year.

[Updated 3/29/13] The drug has been priced at a wholesale acquisition cost of $54,900, says Kate Naizi-Sai, a Biogen Idec spokeswoman.

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  • Nancy

    THANKYOU!!!! Just received word today that the Copaxone I have been on since October,has not helped!! Was waiting for this drug to be approved–perfect timing. When can MS patients get it———–

    • nancy

      BG12 that is!!

  • Therese

    I’ve been waiting 8 yrs for this!!! No more needles and a safe drug with little risky side effects. Way to go Biogen- what’s next?

  • Ike

    Perfect timing. Getting off of Copaxone. Been on it for over a year and I don’t think it was working. Recently had two bad Adverse Reactions that seems to kicked my MS in to moving again. Not good. BG-12 seems like my answer.

  • http://www.facebook.com/emily.mainzer.5 Emily Mainzer

    Oh great to hear about that approval from fda. Recently fda also cleared
    CryoLife’s new Hemodialysis outflow device !
    http://www.medicaldevices-business-review.com/news/fda-clears-cryolife-new-hemodialysis-reliable-outflow-device-050413