Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis (MS). The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy (PML). This marks the third risk factor identified to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI, a highly effective treatment for relapsing forms of MS.
"This label change marks an important advance in assisting people with MS and their physicians to make better-informed decisions concerning the challenges of balancing effectiveness with safety," said Dr. Nicholas LaRocca, Vice President Heath Care Delivery and Policy Research at the National MS Society. "We are encouraged by the proactive role that Biogen Idec and Elan are taking in addressing PML risk stratification."
Infection with the JC virus (JCV) is required for the development of PML and the new label states that anti-JCV antibody negative status indicates that exposure to the JC virus has not been detected. Patients who are anti-JCV antibody positive have a higher risk of developing PML. Patients who are anti-JCV antibody positive, have received prior immunosuppressant (IS) therapy and received treatment with TYSABRI for more than two years have the highest risk of developing PML.
"TYSABRI has benefited thousands of patients worldwide who are living with multiple sclerosis, an often devastating disease affecting people in the prime of their lives," said George Scangos, Ph.D., Chief Executive Officer, Biogen Idec. "Biogen Idec and Elan's use of novel research and scientific expertise has allowed us to gain a better understanding of the benefit-risk profile for TYSABRI. Our development of the risk stratification algorithm and subsequent efforts to support the commercial availability of anti-JCV antibody testing reflect our commitment to providing patients and their physicians with additional guidance to help them make more personalized treatment decisions."
The label update was based on analysis of data from Biogen Idec's and Elan's quantitative risk stratification algorithm, which was presented at a number of major international medical meetings, including the American Academy of Neurology's annual meeting in April, 2011. In the analysis, patients who were anti-JCV antibody positive were at an increased risk for developing PML with varying degrees of risk depending on prior IS use and TYSABRI treatment duration. Irrespective of MS treatment, approximately 55 percent of MS patients are anti-JCV positive.
"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, Chief Executive Officer, Elan. "This further confirms the utility of the anti-JCV antibody status, which along with prior IS use and treatment duration enables the identification of differing levels of risk."
The FDA has granted Quest Diagnostics (NYSE: DGX), the world's leading diagnostic company, a de novo classification petition for the STRATIFY JCV Antibody ELISA testing service. STRATIFY JCV allows neurologists to determine their MS patients' anti-JCV antibody status and is the first blood test to be FDA authorized for the qualitative detection of antibodies to the polyomavirus JC virus.