Posted by: Thixia | October 3, 2008

Avonex study – Enrollment Complete – 15-year follow up

Enrollment Complete in 15-Year Long-Term Follow-Up Study Evaluating Impact of AVONEX(R) in Patients with Relapsing Multiple Sclerosis Enrollment Complete in 15-Year Long-Term Follow-Up Study Evaluating Impact of AVONEX(R) in Patients with Relapsing Multiple Sclerosis

 

Biogen Idec today announced that enrollment is complete in the ASSURANCE trial, a long-term follow-up study which will assess up to 15 years of AVONEX(R) (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.

 

 

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.

 

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