The FINANCIAL — Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) on April 18 announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for inclusion of an additional risk factor, anti-JC virus (JCV) antibody status, to the product label for TYSABRI(R) (natalizumab) in the European Union (EU). The CHMP has also adopted a positive opinion for the five year renewal of the Marketing Authorisation for TYSABRI.
The addition of anti-JCV antibody status as a risk factor allows for a three-factor approach to risk stratification. Prior immunosuppressant therapy and TYSABRI treatment duration are established risk factors previously included in the product labeling. This provides an opportunity to identify patients at lower or higher risk for the development of progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection, according to the company.
"We are pleased the CHMP has recommended adding anti-JCV antibody status as a third important risk factor for PML to the TYSABRI product label. By identifying and understanding the multiple factors that are part of the benefit-risk equation, patients can be informed and empowered to engage in a discussion with their physician about choosing the right therapy for their MS. We are working diligently to make our CE-marked assay broadly available to European physicians at the time of the product label change," said Douglas E. Williams, Ph.D., executive vice president, research and development at Biogen Idec. "Patient safety is our utmost concern. We are dedicated to better understanding PML and have several ongoing initiatives designed to identify additional factors that may further mitigate the risk."
"The decision to prescribe TYSABRI requires consideration of an individual's expected or observed benefit, as well as the risk of potential adverse events associated with treatment," added Eliseo Salinas, M.D., M.Sc., chief medical officer at Elan. "All potential risk factors should be considered when making a decision about the appropriate treatment."