ELAN, BIOGEN SUBMIT SBLA FOR TYSABRI IN CROHN'S DISEASE

Elan and Biogen Idec have announced the submission of a supplemental biologics license application (sBLA) to the FDA seeking approval to market Tysabri (natalizumab) as a treatment for patients with moderately to severely active Crohn's disease.

The filing is based on the results of three randomized, double-blind, placebo-controlled, multicenter trials of Tysabri assessing the safety and efficacy as both an induction and maintenance therapy: ENCORE, ENACT-1 and ENACT-2. The filing also includes proposed labeling and a risk management plan, both of which are similar to those approved for the multiple sclerosis (MS) indication.

In the U.S., Tysabri is approved as a monotherapy treatment for relapsing forms of MS. It is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the U.S. only through a restricted distribution program called the TOUCH Prescribing Program. Biogen Idec had voluntarily withdrawn Tysabri from the market in 2005 following two deaths associated with its use, and the FDA decided in June it could begin marketing it again under this program

In the European Union, Tysabri is indicated as a single disease-modifying therapy in highly active, relapsing-remitting MS patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving, severe, relapsing-remitting MS.