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And the Multiple Sclerosis (MS) Society is optimistic about the possibilities. The New England Journal of Medicine published the results from two third-phase clinical trials of the drug.
"Anytime something new, especially an oral treatment like BG-12, comes on the market it means that another group of people might have the medication they need to really stop the progression of the disease," says Megan Vaughan, program manager with the MS Society's Buffalo office.
Multiple Sclerosis is a condition in which lesions form in a person's brain or spinal cord and affects an individual's legs, ability to walk, and their cognitive abilities. The condition is different for everyone who has MS, Vaughan says.
As of now, Vaughan says those dealing with MS have nine drugs to choose from for relapsing forms of MS, but only one, as of now, can be taken orally. Vaughan says a second oral drug would mean some patients could avoid the injections.
"For a lot of people that ... feeling really gives them a lot of hope about the course of their illness," she says.
The Food and Drug Administration is reviewing an application for marketing approval for BG-12.
The MS Society also provided the following thoughts on the condition and its treatment.
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- The BG-12 study results look quite good and suggest, based at least on the two-year study period, that this may be an effective treatment for relapsing forms of MS. Treatments like this one that stop immune attacks are an important tool which neurologists can use to try prevent damage to the nervous system. If approved by the FDA, it would add to a growing number of options on treatments for relapsing MS. This is good news for people with relapsing MS, the most common form of the disease.
- The increasing number of treatment options is extremely important, since MS affects each person diagnosed in a unique and personal way. In fact, the hallmark of MS is its unpredictability.
- While there are some side effects associated with the use of BG12, as with all MS medications, these appear to be manageable. The safety profile reported in the papers looks quite good. These trials, however, lasted only two years, so it will be important to understand and monitor this therapy’s potential long-term benefits and risks.
- This is a very encouraging time in MS research. The current international collaborative focus on MS research has taken multiple sclerosis from an untreatable disease in 1993 to one where there are now 9 disease modifying therapies available on market for those with relapsing MS, the most common form of the disease, and a half dozen more in late stage development or already before the FDA, such as BG-12.
- Attached is a link to the late stage research in progress for relapsing MS and the significant research under development for progressive MS, the next frontier in MS treatment, which you can share with those who would like to get a better understanding of the work underway to stop MS, restore function lost to MS, and end MS forever.