The FDA’s Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will jointly review Tysabri, a humanized monoclonal antibody, for the treatment of Crohn’s disease (CD) on July 31, 2007.
This follows Elan and Biogen’s supplemental biologics license application for Tysabri as a treatment of moderately to severely active CD, which was submitted to the FDA on December 15, 2006.
The companies’ application included the results of three placebo-controlled, multi-center trials of Tysabri, assessing the drug’s safety and efficacy as both an induction and maintenance therapy.
Tysabri is approved by the FDA to treat multiple sclerosis, but can only be prescribed under certain conditions after safety concerns led to a market withdrawal.
Tysabri is believed to block entry of inflammatory immune cells into the wall of the intestine, therefore limiting inflammatory damage in CD. According to the companies, this drug is the first potential treatment for CD with this proposed mechanism of action.