Category: Latest News

Cladribine is an investigational oral drug being studied for the long-term treatment of relapsing forms of multiple sclerosis (MS). It was submitted to the United States Food and Drug Administration (FDA) for approval earlier this year, receiving Fast Track status in July 2010. Fast Track status reduces the FDA’s review time from 10 months down to six – and a decision was expected by November 28, 2010. However, the agency has extended the review time by three months, with a decision now anticipated by February 28, 2011.

On October 29, 2010, Avanir Pharmaceuticals, Inc. announced the approval of Nuedexta™ by the Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis (MS). PBA is characterized by uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display. PBA occurs involuntarily with little or no stimulation to invoke such a response. It can greatly impact social situations and overall quality of life, both for the patient and his or her family.

Novartis Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) as a first-line treatment for relapsing forms of multiple sclerosis (MS). Gilenya is the first oral disease-modifying therapy available for the long-term treatment of MS. The approval of a treatment that may be taken orally (by mouth), versus injection or infusion, is exciting news for members of the MS community.

The oral medication FTY720 (fingolimod) has moved another step closer to approval as a new disease-modifying therapy for MS. The United States Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee reviewed the clinical trial data submitted by Novartis Pharmaceuticals Corporation (makers of FTY720), and reported its findings at a meeting held on June 10, 2010.

Biogen Idec and Facet Biotech Corporation, developers of daclizumab, report that when added to an interferon regimen, this drug reduces the number of new or enlarged MS lesions in patients with active, relapsing forms of MS. Additionally, daclizumab showed an increase in the number of a certain type of cell that helps to regulate the immune system. These results were published in the online edition of The Lancet Neurology and in the April 2010 issue of The Lancet Neurology.

In February 2010, Teva Pharmaceutical Industries Ltd. announced the publication of their data from 15 years of prospective and continuous evaluation of Copaxone®. The 15-year study findings appeared in the February 2010 issue of the journal, Multiple Sclerosis. Given the positive results, this study has been extended to 20 years, and is presently in its 19th year. Copaxone is given via daily subcutaneous injections and is approved for individuals with relapsing-remitting MS (RRMS).

In January 2010, the results from two large Phase III trials with oral FTY720 (fingolimod) were published in The New England Journal of Medicine. According to a press release from Novartis Pharmaceuticals Corporation (makers of FTY720), the TRANSFORMS and FREEDOMS studies showed positive results in reducing relapses, disability progression, and MRI lesions when MS patients were given FTY720.

The United States Food and Drug Administration (FDA) has approved Botox® (onabotulinumtoxin A) for the treatment of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Manufactured by Allergan, Inc., this drug is administered via injection by a medical professional and is available through prescription only.

The Multiple Sclerosis Association of America (MSAA) encourages everyone to take time this March to learn about multiple sclerosis (MS) and discover all of the programs and services MSAA offers to everyone affected by MS.

Jimmie Heuga, founder of The Heuga Center for Multiple Sclerosis in Colorado, passed away on February 8, 2010. Renamed "Can Do Multiple Sclerosis," this center continues to carry on Heuga’s philosophy and passion for teaching individuals with MS to live life to the fullest.