Biogen/Elan's Antegren filed for MS in USA

Ireland's Elan Corp and USA-based biotechnology firm Biogen Idec have submitted a Biologics License Application to the US Food and Drug Administration for the use of Antegren (natalizumab) in the treatment of multiple sclerosis.

The filing included one-year data from two ongoing Phase III trials. The AFFIRM study is a two-year, randomized, placebo-controlled, double-blind trial involving around 900 patients, which is examining the ability of Antegren to slow the progression of disability in MS and reduce the rate of clinical relapses. Furthermore, the SENTINEL study, also a two-year, randomized, placebo-controlled, double-blind trial, is comparing the efficacy of Antegren in combination with Avonex (interferon beta-1a) to that of Avonex alone, in around 1,200 MS patients.

Antegren is a humanized antibody which is the first alpha-4 antagonist in the new selective adhesion molecule inhibitor class. The companies recently announced their intention to submit a Marketing Authorization Application to the European Medicines Evaluation Agency in the fourth quarter of 2004 for use of the agent as a treatment for Crohn's disease (Marketletter May 24). Antegren is also undergoing Phase II evaluation for rheumatoid arthritis (Marketletters passim).