The European Medicines Agency (EMEA) has received two reports of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS). PML occurred after the two patients had been treated with the sclerosis medicine Tysabri®.
You can read the EMEA's press release about Tysabri® in the factbox to the right.
PML is a rare brain infection with symptoms that are similar to those of an MS attack.
The two incidents of PML were reported in patients who had been treated with Tysabri® for more than 12 months. The cases were reported as part of the continuous safety-monitoring of medicines following their authorisation and placing on the market.
The risk of PML with Tysabri® is known and is kept under close monitoring by the EMEA. The product information advises that the medicine must not be used in patients who have PML and that patients treated with Tysabri® should be regularly monitored for signs and symptoms suggestive of PML.
The two cases are currently being assessed by the EMEA's Committee for Medicinal Products for Human Use (CHMP), and Elan, the marketing authorisation holder for Tysabri®, has also been asked to provide any additional information they may have. When the CHMP has concluded its assessment of all available data, it will determine whether it is necessary to make changes to the currently approved product information or the existing risk minimisation measures, including the information communicated to doctors and the management guidelines applicable to multiple sclerosis patients receiving Tysabri®.
For further information, please contact Chief Medical Officer Marianne Orholm, tel. +45 4488 9740 or the Consumer Safety Division, tel. +45 2246 7811.
Danish Medicines Agency, 13 August 2008