Biogen’s MS ORAL Drug Tecfidera (BG12) Wins FDA Nod

SILVER SPRING, Md. — Dimethyl fumarate has won FDA approval to treat relapsing-remitting forms of multiple sclerosis and will be sold under the name Tecfidera, the agency said Wednesday.

Manufactured by Biogen Idec, the drug is also known as BG-12. It becomes the third oral disease-modifying medication available to treat MS. Others include fingolimod (Gilenya) and teriflunomide (Aubagio).

Dimethyl fumarate has a novel mechanism of action relative to existing MS drugs. It is believed to activate the nuclear factor-like 2 transcriptional pathway, thereby reducing oxidative stress that contributes strongly to demyelination.

The drug has also been used for many years in Europe and elsewhere to treat psoriasis, and has also been used as a fungicide and desiccant in furniture manufacture.

Two placebo-controlled phase III trials served as the basis for approval, the agency said. Called DEFINE and CONFIRM, they enrolled a total of some 2,700 patients. In addition to comparing the drug with placebo, CONFIRM included a third arm with open-label glatiramer acetate (Copaxone), a standard injectable MS drug.

Both trials demonstrated that dimethyl fumarate was superior to placebo in preventing relapses and delaying disability progression. It also appeared to be somewhat more effective than glatiramer acetate in CONFIRM.

The most common adverse effects were gastrointestinal complaints and flushing. The FDA also noted that the drug carries a risk of lymphocytopenia, although infections did not appear to be increased as a result in the phase III studies.

“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, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement announcing the approval.

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