Cladribine: An Oral Medication for MS

Previously, we discussed a new MS drug (Ampyra) that improves the walking ability of those with multiple sclerosis and is set to be introduced in March of this year. It is the first drug of its kind that addresses a specific symptom of the condition. Now another drug is looking promising for the treatment of multiple sclerosis. The study of the drug, Cladribine, is being published in the New England Journal of Medicine.

Cladribine is a medicine that is currently used as a chemotherapy medicine that helps treat hairy cell leukemia. It can be taken orally and would be the first tablet medication used for the treatment of multiple sclerosis. What is more is that this particular medication would only need to be taken for eight to ten days a year. This is far better than multiple sclerosis therapies currently being used, as most require that drugs be administered intravenously and with injections. Further, being able to take a medication less than once a month would allow people to go about their daily activities, which are already limited by the condition itself. In fact, multiple sclerosis can become so debilitating that individuals are forced to stop working and seek social security benefits because of the neurological problems that develop over time.

The drug study followed 1300 multiple sclerosis patients for two years and used MRI scans to evaluate the progression of the disease, looking for relapses or deterioration. The patients were either given a dose of Cladribine or a placebo. The researchers found that those participants taking the Cladribine were fifty-five percent less likely to have a relapse of MS and thirty percent less likely to have the disability worsen. Those taking the placebo reported no improvement in their symptoms or in a decrease of relapses.

The next step is for the drug manufacturer, MD Serono, to request approval from the Food and Drug Administration to market the tablet, which it has already done. The Administration, however, has issued a “refuse to file” letter, which means that additional information or data is required. This could mean that the drug will have to undergo more studies, specifically geared toward multiple sclerosis treatments. With the backing of the National Multiple Sclerosis Society, Serono is sure to produce the necessary paperwork and re-submit the application. It would certainly be a breakthrough for multiple sclerosis patients, and hopefully, it represents a new trend toward oral medications for the disease.