The United States Food and Drug Administration (FDA) recently made some changes to the product labeling for Tecfidera® (dimethyl fumarate). These changes instruct physicians on how to best prescribe the drug for their patients to minimize the potential for certain side effects and adverse events. The revisions are described below; please note that several of the definitions given are from MedlinePlus (from the National Institutes of Health).

On December 1, 2014, Novartis announced that their Phase III INFORMS trial with Gilenya® (fingolimod) for individuals with primary-progressive multiple sclerosis (PPMS) did not meet its primary endpoint. Presently, this disease-modifying therapy, taken orally (by mouth), is approved for the long-term treatment of relapsing forms of MS. The hope was that Gilenya would also prove effective in treating PPMS, a less-common form of MS that presently has no approved treatments available to slow disease activity.

The United States Food and Drug Administration (FDA) announced today that Lemtrada™ (alemtuzumab) has been approved for the long-term treatment of relapsing forms of multiple sclerosis (MS). Given via intravenous (IV) infusion for a course of five days and followed one year later by a second three-day course, Lemtrada has been approved as a second-line therapy. This classification refers to a drug that may only be prescribed when other FDA-approved treatments fail or are not tolerated well by a patient. Lemtrada should generally be prescribed for patients who have had an inadequate response to two or more of the disease-modifying therapies, because of the medication’s safety profile.

Genzyme, a Sanofi company, has announced that the United States Food and Drug Administration (FDA) approved adding the data from two Phase III studies to Aubagio®’s (teriflunomide) product label. These studies are the TOWER and TOPIC studies, which provide additional study results for Aubagio’s efficacy and safety. Aubagio was approved by the FDA in September 2012 and was the second of three (to date) oral medications approved as a disease-modifying therapy (DMT) for relapsing forms of MS.

The Multiple Sclerosis Association of America (MSAA) is pleased to announce the launch of My MS Journey, a new website addition accessed at mymsaa.org/journey. My MS Journey has been designed to guide individuals with multiple sclerosis (MS) to the relevant information that best matches their needs – whether newly diagnosed or coping with the disease for many years.

On August 20, 2014, MSAA posted a news item announcing that the Multiple Sclerosis Coalition (MSC) had published a paper detailing the current evidence that supports the FDA-approved disease-modifying therapies (DMTs) for the long-term treatment of multiple sclerosis (MS). Experts from member organizations of the MSC, including the Multiple Sclerosis Association of America (MSAA), collaborated to write this paper expressly for healthcare providers and the health-insurance industry, using a highly detailed and scientific style. The primary goal of developing this paper is to promote early and ongoing access to all of the presently approved DMTs for individuals with MS.