FDA Advisors Okay Novartis AG's MS Pill

Editor's note: There are quite a few ongoing studies that explore the alternative options for multiple sclerosis patients. Nutrition has been known to play a role in the development and outcome of the disorder. Those who don't feel comfortable with toxic drugs may want to consider these options.

Novartis AG's experimental multiple sclerosis (MS) pill has won the recommendation of the Food and Drug Administration's advisory panel, media reports say.

Gilenia, also known as fingolimod and owned by Mitsubishi Tanabe Pharma Corp, is just like many other drugs available to treat MS in that it does not “cure” the condition.  However, it is recommended as an initial treatment option for all MS patients to help reduce and delay patient symptoms.  

The panelists cautioned and the FDA is concerned because the drug comes with quite a few noteworthy side effects; the panel says that more data is needed regarding these side effects.

Because of this, the FDA’s outside advisory panel recommends patients be educated and aware that the MS pill can result in serious side effects, even though the benefits over-weigh the risks.

It's rare for the FDA to reject recommendations from its own advisory panels. The approval of Novartis' medication is expected in September.

Novartis was cited as telling the panel that the drug is easier to use than other drugs, specifically, those that are injectable forms of medications for MS, some of which may cause flu-like symptoms.

Injectable medicines already on the market are made by Biogen Idec Inc, Bayer AG, Merck kGaA, and Teva Pharmaceutical Industries Ltd.

Earlier, Merck attempted to obtain approval from the FDA for its cladrinine, also indicated to treat MS. Other drug makers are also ready to apply for marketing their MS drugs in the United States, including Biogen's BG-12, Sanofi-Aventis SA's teriflunomide and Teva's laquinimod.

Multiple sclerosis is a nervous system disease, even though some researchers consider it an autoimmune disease, that affects the brain and spinal cord.

The disease, which often begins between ages of 20 and 40, causes a range of symptoms including visual disturbances, muscle weakness, trouble with coordination and balance, sensations such as numbness, prickling, or "pins and needles" and cognition and memory problems.

Multiple sclerosis has a nutritional link.  For example, a recent study has found vitamin D insufficiency substantially increased the subsequent relapse rate in pediatric-onset MS or clinically isolated syndrome.

The study was conducted by Bacchetti P and Waubant E. from the University of California, San Francisco and published in the May 2010 issue of Annals of Neurology.

By David Liu and editing by Rachel Stockton