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November 28, 2004

FDA GRANTS ACCELERATED APPROVAL OF TYSABRI FOR MS

Topics: Clinical Pharmacology

FDA News Drug Pipeline Alert:

Biogen Idec and Elan Corporation announced that the FDA has approved TYSABRI(R) (natalizumab), formerly referred to as ANTEGREN(R), as treatment for relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical relapses. FDA granted accelerated approval for TYSABRI following priority review based on one-year data from two Phase III studies, the AFFIRM monotherapy trial and the SENTINEL add-on trial with
AVONEX(R)(Interferon beta-1a).

TYSABRI, the first humanized monoclonal antibody approved for the treatment of MS, inhibits adhesion molecules on the surface of immune cells. Research suggests TYSABRI works by preventing immune cells from migrating from the bloodstream into the brain where they can cause inflammation and potentially damage nerve fibers and their insulation.

AFFIRM is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide, in which
patients were randomized to receive either a fixed 300 mg IV infusion dose of TYSABRI (n=627) or placebo (n=315) every four weeks. TYSABRI reduced the rate of clinical relapses by 66 percent relative to placebo (p<0.001), the primary endpoint at one-year.

The annualized relapse rate was 0.25 for TYSABRI-treated patients versus 0.74 for placebo-treated patients.  Approval was also based on the results of another Phase III clinical trial, SENTINEL. SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide. In the SENTINEL trial, AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.

Posted by Hyscience at November 28, 2004 1:55 AM

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Comments

Posted by: Linda Santos at November 29, 2004 1:25 AM

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