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.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- Cincy officer indicted on murder charge in fatal shooting of motorist
- Feds accuse Philadelphia congressman Fattah of corruption
- Obama hopes he has enough votes to sustain a potential veto of Iran nuke deal; pro-Israel groups aim to stop it
- House approves bill targeting VA staffers
- 911 dispatcher hung up on caller before wounded teen’s death in June
- Clinton to testify before House committee on Benghazi in October
- New TSA administrator vows training to address security gaps
- Cruz switches targets, takes exception with IRS practices
- Calif. oil slick expected to dissipate
- Strong El Niño event could ease drought in Calif., according to models
- Swimmers dunk in newly cleaned N.Y. lake