Biogen Idec said yesterday it will launch its newest drug Tecfidera™ (dimethyl fumarate) in the U.S. “in the coming days” after winning FDA approval for first-line oral treatment of relapsing multiple sclerosis (MS).

Tecfidera is Biogen Idec’s fourth MS drug. The treatment showed in clinical trials it could significantly reduce relapses and development of brain lesions, as well as slow progression of MS over time.

“We will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill—a combination we believe will have a significant positive impact on the way people live with this chronic disease,” George A. Scangos, Ph.D., Biogen Idec’s CEO said in a statement. “We believe Tecfidera will raise expectations for what people living with MS can achieve with their therapy.”

Tecfidera has wowed analysts in the two years since the first positive clinical trial results were reported, since it is easier to take than current MS drugs that require injection or intravenous infusion, such as two of the other Biogen Idec treatments, Avonex and Tysabri. Earlier this month a consensus of analysts told Bloomberg they expected Tecfidera to rack up, on average, $3.25 billion in annual sales by 2017.

The current sales leader among MS drugs is Teva Pharmaceutical Industries’ Copaxone, which generated $3.996 billion in 2012 sales, up nearly 12% from 2011. Last month, Teva stated that it planned in March to submit to FDA a supplemental New Drug Application for marketing approval of a three-times-weekly dose of Copaxone.

FDA’s approval came five days after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on March 22 recommended the drug for market authorization. The European Commission has final say on drugs approved for use on the continent, but typically abides by CHMP recommendations.

FDA based its approval of Tecfidera on data from DEFINE and CONFIRM, two global Phase III studies that enrolled more than 2,600 patients combined. DEFINE results included a 49% reduction in patients who relapsed, a 53% drop in the annualized relapse rate (ARR), and a 38% decrease in disability progression over 12 weeks.

CONFIRM results showed a 44% decline in ARR and a 34% reduction in patients who relapsed over two years compared to placebo. They also showed a 21% reduction in 12-week confirmed disability progression, which was deemed not statistically significant.

In both trials, Tecfidera “significantly” reduced lesions in the brain when measured via MRIs compared to placebo. DEFINE and CONFIRM required patients to take Tecfidera twice-daily.

Additionally, Biogen Idec has followed some patients receiving Tecfidera for more than four years through the ongoing ENDORSE extension study.

The most common side effects associated with Tecfidera were flushing and gastrointestinal events such as diarrhea, nausea, and abdominal pain. Flushing symptoms usually began soon after the start of treatment, were mostly mild to moderate, and usually improved or were resolved over time. The incidence of GI events was higher early in the course of treatment, primarily in the first month, and decreased over time.

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