Since the beginning of 2011, a new drug for multiple sclerosis (MS) has been approved in Germany: The active substance fingolimod allows for the first time a capsule for swallowing - to date, MS preparations had to be injected. In addition, fingolimod offers a novel mode of action. By interfering with the distribution of white blood cells, fingolimod prevents the destruction of myelin shards in the brain, causing the inflammation of the nervous system typical of multiple sclerosis.
Effect of fingolimod
Originally, fingolimod was developed as an artificially produced form of the active ingredient myriocin. It is a metabolite of Isaria sinclairii, a fungus used in Traditional Chinese Medicine (TCM). Because Myriocin is immunosuppressive, fingolimod should be used to suppress the immune system after kidney transplants. Here, however, its mode of action was no better than that of conventional products.
As an MS drug, the drug is now used as a second-line treatment in patients who do not respond to treatment with interferon beta. In addition, fingolimod may be taken by multiple sclerosis patients with a rapidly progressive or very aggressive form of the disease.
The active ingredient starts in the blood: Here, the lymphocytes are prevented from passing from the lymph nodes into the blood. In fact, if misdirected T lymphocytes enter the myelin sheath of nerve cells, they can destroy them, triggering MS-typical symptoms such as motor disorders, paresthesia, mental health problems, and vision problems.
Fingolimod: approval and dosage
Fingolimod has been allowed in Russia and the USA since 2010. The Fingolimod approval in Germany, the rest of the EU and Switzerland took place in the spring of 2011. Previously, two large Phase III studies had been carried out. It has been shown to positively affect the rate of relapses per year, the progression of disability and the number of inflammatory brain lesions in MS patients.
In Germany, Fingolimod is currently sold exclusively under the trade name Gilenya®. The manufacturer recommends taking one capsule of the drug daily, regardless of the meals. One capsule contains 0.5 milligrams of fingolimod.
Fingolimod: side effects varied
In the course of the studies, some side effects of fingolimod could be detected. The active ingredient suppresses even desirable immune responses, which can lead to infections more often. Side effects of fingolimod may therefore be:
- fungal diseases
- a headache
- back pain
- Increased liver values
- lymphocyte deficiency
In addition, there were two deaths in the course of the studies - one patient died of herpes infection, the other of chickenpox. However, these patients had taken a higher dose of fingolimod than is available today. However, due to the possible serious side effects in the EU, fingolimod is only approved for second-line treatment of multiple sclerosis.