Elan and Biogen Idec announce review of Tysabri

Elan and Biogen Idec have announced that two regulator committees are to engage in a review of Tysabri (natalizumab), the Crohn’s disease medication co-marketed by both firms.

This review will be conducted by the gastrointestinal drugs advisory committee and drug safety and risk management advisory committee of the US Food and Drug Administration on July 31st 2007.

A humanised monoclonal antibody, Tsyabri has a novel mode of operation and is believed to work by preventing inflammatory immune cells from entering the intestinal wall.

Last December, Elan and Biogen Idec announced the submission of a supplemental biologics licence application (sBLA) for Tysabri as a treatment for patients with moderate to severely active Crohn’s disease, prompting this review.

Tysabri is currently indicated in the EU as a treatment for highly active relapsing-remitting multiple sclerosis patients exhibiting high disease activity in spite of treatment with beta-interferon, in addition to those with rapidly evolving severe relapsing-remitting forms of the disease.

“This sBLA includes the results of three randomized, double-blind, placebo-controlled, multi-center trials of TYSABRI assessing the safety and efficacy as both an induction and maintenance therapy,” the companies report.

Earlier this month, Biogen Idec reported that Tysabri saw net sales of $48 million (24.3 pounds) for the first quarter of the year, with the company receiving $30 million of revenues as a result of its partnership with Elan.