WESTON, Mass. (AP) – Biogen Idec and Elan Corp. said they have applied to U.S. and European regulators to update prescribing information for the multiple sclerosis drug Tysabri to help classify the risk of a rare but serious brain infection.
The companies want to include anti-JC Virus antibody status in updated product labeling as a potential factor to help stratify the risk of progressive multifocal leukoencephalopathy, a viral infection that leads to death or severe disability. Tysabri increases the risk of the infection.
The companies submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration and a Type II Variation to the European Medicines Agency.
Biogen, based in Weston, Mass., sells Tysabri through a partnership with Elan, an Irish drugmaker. The U.S. company said its share of Tysabri revenue increased 7 percent to $221 million in the third quarter, while Elan said its share rose 13 percent to $215.9 million.
Tysabri was withdrawn from the U.S. market shortly after its launch in February 2005 after being linked to the brain disease. But regulators permitted the drug to return to market in 2006 under a restricted distribution.
Date: December 21, 2010
Source: Associated Press
Filed Under: Drug Discovery
