Cases of PML reported in patients who had not been previously treated with another immunosuppressive medicine

The European Medicines Agency (EMA) has issued new advice for doctors and patients on the potential risks related to the immunosuppressive effect of the multiple sclerosis medicine Gilenya (fingolimod). In particular, new recommendations are given to minimise the risk of progressive multifocal leukoencephalopathy (PML) and basal cell carcinoma in patients treated with Gilenya.

PML is a rare brain infection caused by John Cunningham (JC) virus, which causes symptoms that may be similar to those of a multiple sclerosis attack, and may result in severe disability or death. Basal cell carcinoma is a slow-growing type of skin cancer which almost never spreads to other parts of the body or becomes life-threatening; however, it can be disfiguring if not treated promptly.

The active substance in Gilenya, fingolimod, reduces the activity of the immune system, in particular of certain cells called T cells. Because T cells are involved in fighting disease and infection, patients treated with Gilenya may be at higher risk of developing infections and diseases, including PML and some types of cancer. So far 3 confirmed cases of PML have been reported in patients treated with Gilenya who had not received previous treatment with Tysabri (natalizumab, another immunosuppressive multiple sclerosis medicine). In addition, 151 cases of basal cell carcinoma have been reported.

EMA has now recommended that patients should be evaluated before and during treatment with Gilenya to allow early identification of signs and symptoms that could be linked to PML or basal cell carcinoma and treat patients accordingly. Before starting treatment with Gilenya, a baseline MRI scan should be available (usually within 3 months) as a reference. If PML is suspected, MRI should be performed immediately and treatment with Gilenya should be suspended until PML has been excluded. With regard to the risk of basal cell carcinoma, a medical evaluation of the skin is recommended before starting treatment, after at least one year and then at least yearly during treatment with Gilenya. Gilenya must not be used in patients with basal cell carcinoma, or any other type of cancer.

The product information for Gilenya will be updated with information about PML, basal cell carcinoma and other risks associated with the weakening of the immune system, in line with the new recommendations.


Posted on the EMA website on 18 December 2015