Biogen Idec (NASDAQ:BIIB) announced late Friday that the US FDA has approved a change to the safety information on the label for its Tysabri drug, intended for the treatment of multiple sclerosis (MS).
The new label identifies a risk factor that promotes progressive multifocal leukoecephalopathy (PML), a rare, but serious brain infection. Patients receiving Tysabri who have anti-JCV antibodies possess a higher risk, which is now identified on the label.
Dr. Nicholas LaRocca, VP of Health Care Delivery and Policy Research at the National MS Society, said: "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.
"We are encouraged by the proactive role that Biogen Idec and Elan are taking in addressing PML risk stratification."
JCV is a virus that causes PML, a devastating brain infection that often leads to death or severe disability. Patients receiving Tysabri who test positive for the anti-JCV antibody are at a higher risk of developing PML than those who are not.
Biogen Idec, and its development partner, Elan (NYSE:ELN), have developed an FDA-approved assay service to determine MS patients' anti-JCV antibody status. The assay will be exclusively offered by Quest Diagnostics (NYSE:DGX).
Biogen Idec CEO Dr. George Scangos commented: "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.
"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."
Tysabri is already approved in over 65 countries, including in the U.S. as a monotherapy for relapsing forms of MS, and in the EU for highly active relapsing-remitting MS.
The U.S. label change follows the approval of a similar change in the EU, where about 59,000 anti-JCV antibody status tests have been performed during the third quarter of 2011 alone.
In premarket trading on Monday, Biogen Idec shares rose 0.3 percent to $118.50, as of 8:53 am EDT. In 2011, the company’s stock gained 64.13 percent.