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EMA approves Gilenya to treat adults with highly active multiple sclerosis (MS)

Gilenya is a medicine that contains the active substance fingolimod. It is available as capsules (0.5 mg).

Gilenya is used to treat adults with highly active multiple sclerosis (MS). MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells. Gilenya is used in the type of MS known as ‘relapsing-remitting’, when the patient has attacks (relapses) in between periods with decreased symptoms (remissions). It is used when the disease has failed to respond to a beta-interferon (another type of medicine used in MS), or is severe and getting worse rapidly.

The medicine can only be obtained with a prescription.

Treatment with Gilenya should be started and supervised by a physician experienced in MS. The recommended dose is one capsule taken once a day by mouth.

In MS, the body’s immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord). The active substance in Gilenya, fingolimod, reduces the ability of T cells (a type of white blood cell involved in the immune system) to move from the lymph nodes towards the brain and spinal cord thus limiting the damage they cause in MS. It does this by blocking the action of a receptor on the T cells called the sphingosine-1-phosphate receptor, which is involved in regulating the movement of these cells in the body.

The effects of Gilenya were first tested in experimental models before being studied in humans.

Gilenya at two doses (0.5 mg and 1.25 mg) was investigated in two main studies in MS patients. In one study, Gilenya was compared with placebo over two years in 1,272 patients with relapsing-remitting MS. In the second study Gilenya was compared with beta-interferon over one year in 1,292 patients. The main measure of effectiveness in both studies was based on the number of relapses the patients experienced each year.

Gilenya was shown to be more effective than placebo and beta-interferon in reducing the number of relapses. The lower dose of Gilenya was shown to be as effective as the higher dose. In the first study, the number of relapses per year among patients treated with Gilenya was around half the number seen in patients given placebo. In the second study, the number of relapses in patients receiving Gilenya was also around half the number seen in patients given beta-interferon.

The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu infections, headache, cough, diarrhoea, back pain and raised liver enzyme levels. For the full list of all side effects reported with Gilenya, see the package leaflet.

Gilenya should not be used in people who may be hypersensitive (allergic) to fingolimod or any of the other ingredients. Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term infection such as hepatitis, cancer (except a type of skin cancer called ‘basal cell carcinoma’) or severe liver problems. Women should avoid becoming pregnant while taking Gilenya and for two months after treatment has stopped.

The CHMP concluded that the effectiveness of Gilenya had been shown and noted that it had the benefit of being taken by mouth. However, because of its safety profile, the Committee concluded that Gilenya should only be used in patients who have a real need for the medicine either because they have failed to respond to a beta-interferon or because their disease is severe and getting worse rapidly. The Committee decided that Gilenya’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The company that makes Gilenya must ensure that all doctors who intend to prescribe Gilenya receive an information pack containing important safety information including a checklist of the risks with Gilenya and the tests and monitoring that should be carried out in patients. The pack will also include information on the registry the company will set up to collect data on babies born to women treated with Gilenya, as well as a patient reminder card with key safety information for patients.

The European Commission granted a marketing authorisation valid throughout the European Union for Gilenya to Novartis Europharm Ltd on 17 March 2011. The marketing authorisation is valid for five years, after which it can be renewed.
For more information about treatment with Gilenya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Source :

European Medicine Agency

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