Label change for Elan's MS-drug permits safer use
Weston/Dublin - The focus for Tysabri, the MS drug jointly developed by Irish Elan and US-Biogen, has become a little more accurate. The US Food and Drug Administration (FDA) stated that the occurrence of antibodies against the JC-virus marks a higher risk of developing progressive multifocal leukoencephalopathy (PML). A new label identifies anti-JCV antibody status as a third risk factor for developing PML. Tysabri (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain which in most cases leads to death or severe disability. With the label update, which the companies say was inspired by their own research, physicians now have others factor at hand when weighing the risks and benefits of applying Tysabri. “We welcome the inclusion of PML risk stratification in the U.S. label as it significantly supports our aim to provide the information patients and physicians need to make a more informed treatment decision,” said Kelly Martin, CEO of Elan. Tysabri is approved in about 65 countries and results in a 68% relative reduction in the annualised relapse rate when compared with placebo, according to studies conducted by Elan.