FDA grants approval for multiple sclerosis medication
WASHINGTON — An oral medication for multiple sclerosis has won the Food and Drug Administration's marketing approval and is to become available almost immediately to patients suffering from the debilitating auto-immune disease.
Tecfidera is the commercial name for dimethyl fumarate, a capsule that won the FDA's blessing this week as a treatment for relapsing MS, a degenerative brain disorder that can impair mobility, sensation and thinking.
In clinical trial evidence submitted to the FDA by Biogen Idec of Weston, Mass., the medication's maker, Tecfidera reduced the proportion of patients who relapsed when compared with a sham medication. In one of those trials, subjects taking Tecfidera showed less progression of the disease compared with those on a placebo. And both trials found that those taking Tecfidera twice daily developed fewer MS-related lesions in the brain.
The medication was formerly known as BG-12.
Those findings held whether patients had newly diagnosed multiple sclerosis or had their multiple sclerosis progress over some years, said Dr. Robert M. Fox, medical director of the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, in a statement issued by Biogen Idec. Fox serves as a paid adviser to the firm and was lead investigator in one of the Tecfidera's earliest trials.
Common side effects of Tecfidera are flushing and gastrointestinal events, including nausea, diarrhea and vomiting. And though no increased rate of infections were noted in those taking Tecfidera in clinical trials, the medication may lower white blood counts and increase infection risk, the FDA said.