Patient Health Protection

Thank you for your query of 6 July 2012 requesting information on the studies of the medicine Gilenya in MS patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI).

The safety of Gilenya has not been specifically studied in patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI), therefore we are unable to provide you further information in this regard.

As referred to in your correspondence, a safety review was recently carried out by the European Medicines Agency. This review was related to cases of death and serious cardiovascular events (problems related to the heart and blood vessels) in patients who had recently started treatment with the medicine, and the product information for Gilenya was subsequently updated to recommend that Gilenya should not be used in patients with a history of cerebrovascular disease. However, if treatment is nonetheless considered necessary, advice from a cardiologist should be sought and an extended monitoring, at least overnight, is recommended after the first dose. For further information, please find below the links to the European Public Assessment Report (EPAR) on this safety review and the Product information:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/002202/WC500129801.pdf

http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002202/WC500104528.pdf

We hope you find this information useful.

Kind regards,

Rosa

Rosa Gonzalez-Quevedo

Medical Information 

European Medicines Agency 

7 Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

info@ema.europa.eu