Advisory committee voted 12 in favor to three opposed, with two abstaining, and two had departed.
An FDA advisory panel vouched in favor of approving Tysabri for moderate-to-severe Crohn’s disease in patients who have failed or cannot tolerate available therapies. Tysabri is already approved for relapsing forms of multiple sclerosis (MS) in the U.S. and relapsing-remitting MS in the EU.
The Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 12 in favor to three opposed, with two abstaining, and two had departed. The panel recommended that the FDA conduct very strict postmarketing surveillance. They also required a meticulous risk management program for Tysabri and for the FDA to put clearly defined endpoints to protect patients and to remove the drug from the market if needed.
Elan, discoverer of the drug, and Biogen Idec, co-developer, report that they will continue to work closely with the FDA to bring Tysabri to the market for the appropriate subset of patients with Crohn’s disease. Discussions with the FDA will include adapting the existing Tysabri risk-management plan.