Tuesday, June 15, 2010

Oral Therapy for MS Recommended for Approval by FDA Panel

Bookmark and Share
On June 10, 2010, the FDA recommended the approval of a new disease-modifying treatment, known as Fingolimod, for relapsing Multiple Sclerosis. The drug is considered a new class of therapy for the treatment of MS and is effective in binding to the dock site on immune cells, preventing the cells that cause harm to the brain and spinal cord from leaving the lymph nodes. Clinical trials found that the drug was able to successfully reduce the remitting relapse rates and significantly slow the progression of the disease. The lower dosage of the drug displayed fewer side effects in than the larger dose. The side effects included a reduction in heart rate after the first dose, elevation in blood pressure, heart conduction blockage, and macular edema. It is possible that Fingolimod could also be effective for progressive forms of MS, though testing is still in progress. The FDA must now consider the recommendation while reviewing the clinical trials to determine is the drug will be approved and available for people with MS. A final decision is expected later this year in September 2010.

Oral therapies along with other medical advancements for MS, would not be possible without sufficient funding for research. Over the last few years, the funding for the National Institutes of Health has not been adequately adjusted for medical inflation costs. To combat loss of purchasing power, the research community would like an additional $35 billion dollars in research funding for the National Institutes of Health for the fiscal year 2011. Join with the National MS Society to urge Congress to provide additional research funding to NIH as they are making funding decisions for the upcoming year.

The National Multiple Sclerosis Society is proud to be a source of information about multiple sclerosis. Our comments are based on professional advice, published experience and expert opinion, but do not represent therapeutic recommendations or prescription. For specific information and advice, consult your qualified physician.

blog comments powered by Disqus


Bookmark and Share