Biogen Idec announced that enrollment is complete in the ASSURANCE trial, a
long-term follow-up study which will assess up to 15 years of
AVONEX®
(interferon beta-1a) treatment in an effort to provide detailed data on the long
term efficacy of the drug. ASSURANCE is a multi-center, open-label follow-up
study of patients with relapsing multiple sclerosis (MS) treated with AVONEX or
placebo for at least two years in the phase III pivotal trial. In the trial, 136
of a possible 172 patients were identified for this study at four major MS
centers including: Cleveland Clinic Foundation, The State University of New York
at Buffalo, Oregon Health and Science University and Georgetown University
Medical Center.
The 15-year follow-up study is designed to determine the
effect of long term AVONEX treatment on disability progression and quality of
life. Additionally, the study will assess the impact of treatment on patients'
independent living ability. Outcomes of this study will potentially provide
further evidence of the benefits of initial and continued treatment with AVONEX.
"We are conducting this study to show further evidence that patients who
stay on treatment achieve long-term clinical benefits even after 15 years," said
Dr. Bianca Weinstock-Guttman, associate professor of neurology and director
Baird MS and Pediatric MS Center, Jacobs Neurological Institute at SUNY
University at Buffalo. "Because of the chronic nature of MS, it is important for
patients to start on an effective therapy as soon as possible to help reduce
relapses, delay physical disability progression and protect to help prevent
future disability. It is equally important that it is a therapy that they can
stay on for the long run.
The 15-year follow-up study targeted the 172
patients who completed at least two years of treatment in the original AVONEX
phase III pivotal trial. The pivotal trial showed that treatment with AVONEX
significantly slowed the accumulation of physical disability, and time to
sustained progression in EDSS score was significantly lengthened in patients
treated with AVONEX as compared to placebo. Final results of the ASSURANCE
15-year follow-up study are expected to be released in Q3 2008.
About
AVONEX AVONEX is the most prescribed treatment for relapsing forms
of MS worldwide, with more than 130,000 patients on therapy. It was launched in
the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS
to slow the progression of physical disability and reduce relapses. It was later
launched in Europe. AVONEX has been proven effective for up to 3 years in
clinical trials. AVONEX was the first treatment approved for patients who have
their first clinical MS attack and have a brain MRI scan consistent with MS;
this use was approved in Europe in 2002 and in the U.S. in 2003. AVONEX is
marketed internationally in more than 90 countries.
The most common side
effects associated with AVONEX multiple sclerosis treatment are flu-like
symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting,
pain and asthenia.
AVONEX should be used with caution in patients with
depression or other mood disorders and in patients with seizure disorders.
AVONEX should not be used by pregnant women. Patients with cardiac disease
should be closely monitored. Patients should also be monitored for signs of
hepatic injury. Routine periodic blood chemistry and hematology tests are
recommended during treatment with AVONEX. Rare cases of anaphylaxis have been
reported. Please see complete prescribing information available at
http://www.AVONEX.com.
Safe Harbor/Forward Looking
Statements This press release contains forward-looking statements
regarding AVONEX that are subject to a number of risks and uncertainties. These
statements are based on the companies' current beliefs and expectation. No
forward-looking statement can be guaranteed. Drug development involves a high
degree of risk. Factors which could cause actual results to differ materially
from the companies' current expectations include: the risk that unexpected
concerns may arise from additional data or analysis or that the company may
encounter other unexpected hurdles. For more detailed information on the risks
and uncertainties associated with Biogen Idec's drug development and other
activities, see the periodic reports of Biogen Idec Inc. filed with the
Securities and Exchange Commission. Biogen Idec assumes no obligation to update
any forward-looking statements, whether as a result of new information, future
events or otherwise.
http://www.AVONEX.com
View drug information on
Avonex.
