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EMA adds warning label to Novartis’ MS treatment Gilenya

Published on 22/12/15 at 10:16am

Drug safety regulators in Europe have said they will add warnings to the label and prescribing information of Gilenya (fingolimod), to flag up a possible risk of cancer and of a potentially fatal brain infection.

The EMA will add the information about the infection – called progressive multifocal leukoencephalopathy (PML) – to the drug’s product information immediately, along with the information about basal cell carcinoma. 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.

So far, three cases of PML have been reported in Gilenya patients who had not received previous treatment with Biogen's Tysabri (natalizumab) – another, similar, immunosuppressive MS therapy. And some 151 cases of basal cell carcinoma have been reported, the regulators say.

The risks are thought to be associated with Gilenya’s ability to reduce immune system activity. 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.

There may also be a potential risk with other MS drugs. In a paper published in the New England Journal of Medicine, researchers flagged up a case of PML that was reported in a patient taking Biogen’s Tecfidera (dimethyl fumarate), shortly after Biogen itself reported another case. In the US, the FDA has already updated Gilenya’s label to reflect cases of serious brain infections linked to the treatment.

The EMA is also issuing new recommendations for doctors and patients concerning Gilenya's potential risks. It now says that patients should be evaluated before and during Gilenya treatment in order to flag early signs of PML or skin cancer, and they should receive a baseline MRI scan and a medical skin evaluation before starting treatment.

Lilian Anekwe

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