Treatment Updates

FDA Approves Twice a Day Capsules Called Tecfidera™ (formerly called BG-12) for Relapsing MS

Mar 27, 2013
The FDA has approved Tecfidera™ capsules (dimethyl fumarate, Biogen Idec –formerly “BG-12”) as a first-line disease-modifying therapy for people with relapsing forms of MS. This makes the third oral therapy approved for relapsing MS, and the tenth disease-modifying treatment available in the U.S. Tecfidera is expected to be available by prescription within a few days.

Ginkgo Fails to Improve Cognitive Function in People with MS

Sep 24, 2012
Results of a placebo-controlled, 12-week clinical trial were recently published, showed that Ginkgo biloba failed to improve cognitive function in people with MS. The study involved 121 people with all types of MS whose cognitive tests showed some cognitive impairment. After 12 weeks, no differences were seen between those on Ginkgo and those taking placebo in any of the outcome measures. The study was not designed to determine the long-term impact of Ginkgo. The results were published online on September 5, 2012 in the journal Neurology.

FDA Approves Oral Teriflunomide – Brand Name Aubagio® – as Disease-Modifying Therapy for Relapsing MS

Sep 12, 2012
The U.S. FDA has approved teriflunomide once-daily pills (Aubagio) to treat relapsing forms of MS. This is the second oral disease-modifying therapy approved for the treatment of multiple sclerosis. The therapy is expected to be available for prescription by October 1, 2012 in the U.S.

UPDATE on Tysabri and PML

Aug 16, 2012
As of April 2, 2013 there have been 347 confirmed cases of progressive multifocal leukoencephalopathy (PML, a viral infection of the brain that usually leads to death or severe disability) among people who have used Tysabri® (natalizumab, Biogen Idec) after it became available for prescription in July 2006.

Ampyra Post-Marketing Study Results Announced - Low dose does not improve walking: Approved dose misses primary endpoint but shows benefit in several secondary endpoints

Aug 14, 2012
A post-marketing study of Ampyra® (dalfampradine-ER, Acorda Therapeutics) did not meet its primary endpoint, showing that a low dose (one-half of the approved dose) did not improve walking speed. The dose approved by the U.S. Food and Drug Administration (FDA) to improve walking in MS did not meet this endpoint in this study either, but did improve walking speed and endurance based on several secondary measures.

FDA Updates Prescribing Info for Ampyra to Address Risk of Seizure in Those with Reduced Kidney Function

Jul 23, 2012
The FDA released a Drug Safety Communication to address the risk of seizures in people with MS who are starting Ampyra (dalfampridine, Acorda Therapeutics). Ampyra was approved in January 2010 to improve walking in people with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug.

Italian Researchers Find that MS Disease-Modifying Therapies Reduce the Risk of Future MS Progression

Jul 03, 2012
Researchers used novel statistical methods to study outcomes for 1178 people with MS from three MS centers in Italy, and concluded that using disease-modifying therapies significantly reduced the risk of progressing from relapsing-remitting to secondary-progressive MS. Roberto Bergamaschi, MD (Neurological Institute C. Mondino, Pavia, Italy) and colleagues report their findings in MS Journal (2012 May 31. [Epub ahead of print]). This novel, investigator-initiated study adds to the body of evidence suggesting that MS therapies improve future outcomes for people with MS.