Antegren Submitted One Year Early for FDA Approval ....
The makers of Antegren® (Biogen Idec and Elan Corporation) announced they are going to be submitting an application for approval of Antegren (natalizumab) as a treatment for multiple sclerosis to the U.S. Food and Drug Administration (FDA) one year earlier than planned. They expect to submit the filing mid-year 2004. The decision came after reviewing the one-year data from the two ongoing two-year phase III trials. The companies did not disclose the one-year data to protect the integrity of the trial.
About the Trial
Approximately 900 patients are participating in the AFFIRM (natalizumab safety
and efficacy in relapsing-remitting MS) trial, a two-year randomized multi-center,
placebo-controlled, double-blinded study. The focus of this trial is to evaluate
Antegren's ability to slow the progression of disability in MS and reduce
the rate of clinical relapses.
The second trial, SENTINEL (safety and efficacy of natalizumab in combination with Avonex® [interferon beta-1a]), includes approximately 1200 patients with relapsing-remitting MS and is a two-year, randomized, multi-center, placebo-controlled, double-blinded study. The study is evaluating the effect of the combination of Antegren and Avonex compared to the treatment with Avonex alone in slowing the progression of disability and reducing the rate of clinical relapses.
The protocol of both studies includes a one-year analysis of the data. The primary endpoints for both phase III two-year trials in MS are based on the Expanded Disability Status Scale (EDSS) and relapse rates.
Background on Antegren Trials
The Motivator has chronicled the development of Antegren from its clinical
phase. The 2002 winter issue of The Motivator article focused on the clinical
trial and previewed both the AFFRIM and SENTINEL trials. The 2003 winter
issue of The Motivator reported on the progress of the two trials and the
important process of affirming the results in a "peer-reviewed" publication.
The results of the study were published in the January 2, 2003 issue of the
New England Journal of Medicine (David H. Miller, et al., A Controlled Trial
of Natalizumab for Relapsing Multiple Sclerosis, vol.348: 15-23). Anyone
wishing to see copies of these two MSAA articles may request them by calling
MSAA's Helpline at (800) 532-7667.
More on Antegren
Antegren works by interfering with the movement of potentially dangerous immune
system cells (activated lymphocytes and monocytes) from the bloodstream across
the blood-brain barrier (BBB), into the brain and spinal cord. Passing through
the BBB is the necessary step for the cells to attack the myelin and cause
damage to the nerves of the central nervous system (CNS). To cross the BBB,
immune system cells must first adhere to the blood vessels. Glycoprotein
alpha 4 integrin appears on the surface of these damaging cells, enabling
them to adhere to the blood vessel walls and then migrate into the CNS. Antegren
is an alpha 4 integrin antagonist, thus interfering with the alpha 4 integrins
ability to move immune system cells into the CNS.
Antegren was originally developed by the Elan Corporation, and has since joined with Biogen Idec Incorporated (makers of Avonex) to test and ultimately seek approval for Antegren.
