EMEA assessing data on Tysabri

Since receiving reports of two cases progressive multifocal leukoencephalopathy in multiple sclerosis patients on Tysabri (natalizumab) recently (Marketletter August 4), the European Medicines Agency (EMEA) has asked the originator, Irish biotechnology firm Elan, to provide any additional information it may have. Following assessment of all available data, the Committee for Medicinal Products for Human Use (CHMP) will decide on possible changes to the currently-approved product information or the existing risk minimization measures, including the Physician Information and Management Guidelines. The predicted blockbuster was co-developed with US biotechnology firm Biogen Idec.