CAMBRIDGE, MA -- January 16, 2001 -- Biogen, Inc. announced that its IMPACT study with Avonex® (interferon beta-1a) in secondary progressive multiple sclerosis (MS) achieved its primary endpoint. Treatment with Avonex reduced the progression of disability of secondary progressive MS by 27 percent versus treatment with placebo.
IMPACT, which stands for International Multiple Sclerosis Secondary Progressive Avonex Controlled Trial, was a randomized, double-blind, placebo- controlled Phase III trial. The study began in 1998 and involved 436 patients at 42 sites in the U.S., Canada, and Europe. The primary objective was to determine whether weekly treatment with Avonex (60 mcg) is effective in slowing the progression of secondary progressive MS, as determined by the multiple sclerosis functional composite endpoint (MSFC). A full presentation of the data is expected at a professional meeting of neurologists in the Spring of 2001.
Burt Adelman, M.D., Vice President, Medical Research, said, "These clinical trial results in patients with secondary progressive MS are very encouraging. We will be reviewing the data with FDA, EMEA, and other regulatory agencies worldwide. Patients with advanced forms of MS need new therapeutic options to help them manage this disease."
Avonex is the most prescribed treatment for MS worldwide. It was launched first in the U.S. in 1996 for the treatment of relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. More than 93,000 patients worldwide are now on Avonex therapy, which is marketed internationally in more than 65 countries.
The most common side
effects associated with Avonex treatment are flu-like symptoms, muscle
ache, fever, and chills. Other common side effects seen, but not statistically
different between Avonex and control groups, were headache, pain and asthenia
(weakness). These side effects usually go away within a day after the injection
and occur less often as the treatment continues.