New drug approved for multiple sclerosis

First-time drug approved for multiple sclerosis

22/03/2011

The European Medicines Commission (EMA) has approved a new compound for the treatment of relapsing remitting (RRMS). For those affected the drug available under the trade name Gilenya® promises a much more pleasant application, since instead of the usual injections once daily the active ingredient fingolimod is taken orally. However, experts also warn against the not minor side effects of the new MS drug. During a study, two subjects had died.

The EMA has taken several studies into account in its decision to authorize the new drug for the treatment of RR multiform sclerosis (RRMS), with two major phase III studies (FREEDOMS, TRANSFORMS) showing that fingolimod may favorably influence the progression of disability and the number of inflammatory brain lesions in MS patients. The side effects such as influenza infections, headache, diarrhea, back pain, colds and increased liver enzymes and lymphopenias (lymphocyte deficiency) are, in the opinion of the EMA in a promising treatment of relapsing remitting multiple sclerosis justifiable.

First oral drug against MS
Multiple sclerosis can be treated as a chronic inflammatory disease of the central nervous system in the future with the help of the daily orally administered ingredient fingolimod. „For many sufferers who are not sufficiently treated with the injections of commercially available active ingredients, there is now a new option with an increase in quality of life“, emphasized the spokesman of the board of the disease-related competence network Multiple Sclerosis (KKNMS), Professor Heinz Wiendl. The KKNMS also welcomed the approval of the drug for the treatment of RR multiple sclerosis, „however, we urge our colleagues, established and clinically active neurologists, to prescribe fingolimod only after careful consideration of the risk-effectiveness profile, as the drug interferes deeply with the patient's immune system“, warned Professor Heinz Wiendl. „Syringe fatigue per se is not an indication“, which justifies the use of the active substance, the expert continued. The KKNMS recommends careful handling of the new drug, especially due to the threat of side effects.

Approval of the new MS drug with restrictions
Fingolimod acts as a so-called sphingosine 1-phosphate (S1P) receptor modulator in the treatment of multiple sclerosis and initiates a reversible redistribution of circulating lymphocytes into the lymph nodes. The lymphocytes are responsible for the development of inflammation in the central nervous system and thus for much of the disease symptoms in multiple sclerosis. By redistributing the lymphocytes, it is therefore possible to achieve significant positive effects in the treatment of MS, as proven by previous studies. In addition, the new drug can also react directly with cells of the central nervous system and here cause a protective effect and a partial restoration of the tissue, the EMA justifies their positive vote for the approval of fingolimod. However, the EMA has coupled the use of the new drug to certain conditions. Fingolimod should only be used in RRMS patients who continue to have high disease activity despite interferon therapy, or who suffered two and more obstructive relapses in one year and had one or more MRI lesions (contrast media) in MRI.

Numerous states allow use of the MS drug
Already two months ago, the Advisory Committee of the EMA recommended an approval of the active substance fingolimod as a once-daily, oral treatment of RR multiple sclerosis at a dosage of 0.5 milligrams. In the United States, the Food and Drug Administration (FDA) has already approved fingolimod at the end of September 2010, with approval without the restrictions imposed in Europe. At the same time as the USA, the active substance was also registered in Switzerland and Australia. Also in the Canadian market Fingolimod is now approved. The EMA has now also given a positive vote, but warns against its frivolity in view of the side effects identified in the Phase III study.

Side effects of the new drug should not be underestimated
For example, the TRANSFORMS study found two serious herpesvirus infections causing death. „Although both patients were treated with a higher dose than the now approved 0.5 mg per hard capsule, this should not be trivialized“, emphasized Prof. Wiendl. In addition, several cases of lymph node enlargement were observed, possibly triggered by therapy with the new drug. Prof. Wiendl emphasized that this is to be expected in total, „that treatment with fingolimod can cause complications, the consequences of which are currently difficult to estimate.“ Therefore, the expert of the KKNMS pleaded „for close monitoring, the results of which are recorded in a safety register“ should. The disease-related competence network multiple sclerosis is currently working on practical information on medication and will soon make it available on its homepage and the guidelines of the German Society of Neurology, explained Prof. Wiendl. (Fp)

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Picture: Rainer Sturm