European Medicines Agency (EMA) reviewing Gilenya (Fingolimod)

A review of Gilenya by the EMA has been initiated following the report of a patient in the USA who died 24 hours after taking Gilenya. The review also includes a total of 11 deaths worldwide, however the causes of these deaths were mixed and the EMA acknowledges that a relationship of these deaths to Gilenya is not established. The exact cause of death in this recent case remains uncertain. However, a temporary slowing of the heart had been experienced in some patients when taking their first dose of Gilenya during clinical trials. This resulted in the recommendation that patients are closely monitored for 6hrs following their first dose. More than 30,000 patients have received Gilenya worldwide, in clinical trials and since its approval. As a precaution and pending the results of their review, the EMA are recommending that European doctors increase their monitoring of patients in the immediate period following the first dose.

No changes have currently been recommended in Australia, however, Novartis Australia has informed the Australian Therapeutic Goods Administration (TGA) of the review. If you have any concerns or questions relating to Gilenya please contact your doctor or pharmacist.

• To view the full EMA press release [click here]
• EMA have produced a Q&A on the ongoing review of Gilenya - [click here]
• An updated Gilenya factsheet from MS Australia is available - [click here]