New drug against multiple sclerosis approved

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Approved drug for the first time against multiple sclerosis

The European Medicines Commission (EMA) has approved a new active ingredient for the treatment of relapsing remitting multiple sclerosis (English relapsing remitting, RRMS for short). For those affected, the preparation available under the trade name Gilenya® promises a considerably more pleasant application, because instead of the usual injections, the active ingredient fingolimod is taken orally once a day. However, experts also warn of the no less side effects of the new MS drug. Two subjects died during a study.

With its decision to approve the new active ingredient for the treatment of RR-Mulitple Sclerosis (RRMS), the EMA has taken the results of several studies into account, whereby two large phase III studies (FREEDOMS, TRANSFORMS) have recently shown that fingolimod increases the annual can favorably affect the progression of the disability and the number of inflammatory brain lesions in MS patients. According to the EMA, the side effects such as influenza infections, headache, diarrhea, back pain, colds as well as increased liver function tests and lymphopenia (lymphocyte deficiency) are justifiable with a promising treatment of relapsing remitting multiple sclerosis.

Active ingredient for the first time to be taken orally against MS multiple sclerosis as a chronic inflammatory disease of the central nervous system can be treated with the help of the daily active ingredient fingolimod. "For many sufferers who are not adequately treated with the injections of the commercially available active ingredients, there is now a new option with a plus in quality of life," emphasized the spokesman for the disease-related competence network Multiple Sclerosis (KKNMS), Professor Heinz Wiendl. The KKNMS also welcomed the approval of the active ingredient for the treatment of RR multiple sclerosis, "however we ask our colleagues, the resident and clinically active neurologists, to prescribe fingolimod only after a careful examination of the risk-effectiveness profile, since the drug goes deep into the drug The patient's immune system intervenes, ”warned Professor Heinz Wiendl. "Syringe fatigue per se is not an indication" that justifies the use of the active ingredient, the expert continued. The KKNMS recommends careful handling of the new drug, particularly because of the impending 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 the circulating lymphocytes into the lymph nodes. The lymphocytes are responsible for the development of inflammation in the central nervous system and thus for a large part of the symptoms of multiple sclerosis. A redistribution of the lymphocytes can therefore achieve significant positive effects in the treatment of MS, as the previous studies have shown. In addition, the new active ingredient can also react directly with cells of the central nervous system and have a protective effect and partial tissue restoration, the EMA justifies its positive vote for the approval of fingolimod. However, EMA has linked the use of the new active substance to certain requirements. Fingolimod may only be used in RRMS patients who continue to show high disease activity despite interferon therapy or who suffered two or more disabling episodes in one year and thereby had one or more lesions (contrast medium-absorbing disease spots) in magnetic resonance imaging, the EMA decided.

Numerous countries allow the use of the MS drug Already two months ago, the advisory committee of the EMA recommended approval of the active ingredient fingolimod as a once-daily, oral treatment of RR-multiple sclerosis at a dose of 0.5 milligrams. In the United States, the Food and Drug Administration (FDA) had already approved fingolimod in late September 2010, with the approval being granted without the restrictions imposed in Europe. At the same time as the USA, the active ingredient was also registered in Switzerland and Australia. Fingolimod is now also approved on the Canadian market. The EMA has now also given a positive vote, but warns against careless use in view of the side effects identified in the Phase III study.

The side effects of the new active ingredient should not be underestimated. For example, the TRANSFORMS study recorded two serious herpes virus infections with fatal consequences. "Although both patients were treated with a higher dose than the now approved 0.5 mg per hard capsule, this must not be trivialized," emphasized Prof. Wiendl. In addition, several cases of lymph node enlargement have been observed, which may have been triggered by therapy with the new active ingredient. Prof. Wiendl emphasized that, overall, it can be expected that “complications can occur with treatment with fingolimod, the consequences of which are currently difficult to estimate.” The KKNMS expert therefore advocated “close monitoring, the results of which are recorded in a safety register should be ". The disease-related competence network Multiple Sclerosis is currently working on practical information on medication and will soon make it available on its website and the guidelines of the German Society for Neurology, said Prof. (fp)

Also read:
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Cannabis cultivation: the seriously ill achieves partial success

Image: Rainer Sturm /

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Video: New drug for MS is milestone for patients and research


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