New Long-Term Data Show That Patients Taking AVONEX(R) for up to 15 Years Experience Reduced Disability Progression and Improved Quality of Life.MONTREAL -- Biogen Idec (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BIIB BIIB Basic Imagery Interpretation Brief ) today announced that data was presented from the ASSURANCE (ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs) study, showing the long-term benefits of AVONEX([R]) (interferon beta-1a interferon beta-1a Avonex, Rebif Pharmacologic class: Biological response modifier Therapeutic class: Antiviral, immunoregulator Pregnancy risk category C ActionIM) therapy in patients with relapsing multiple sclerosis (MS) for up to 15 years. The ASSURANCE study represents the long-term follow-up of patients who participated in the Multiple Sclerosis Collaborative Research Group (MSCRG MSCRG Multiple Sclerosis Collaborative Research Group ), the original Phase III pivotal trial from which AVONEX was approved. Data from this study were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada. This is the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS ACTRIMS Americas Committee for Treatment and Research in Multiple Sclerosis (Canada and US) ) and its counterparts in Europe and Latin America: ECTRIMS ECTRIMS European Committee for Treatment and Research in Multiple Sclerosis and LACTRIMS."As a physician, my goal in treating my MS patients is to delay disability progression and help them maintain their normal lifestyle for as long as possible," said Robert Bermel, MD, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic. "This follow-up study identifies a group of patients who achieved benefits from long-term treatment, and underscores the importance of starting on and continuing an effective therapy for MS." The data from the study show that patients currently taking AVONEX for up to 15 years (range of 3 - 15 years) versus those not on AVONEX therapy reported: * Significantly lower disability progression as measured by a mean change in Expanded Disability Scale Scores (EDSS EDSS Expanded Disability Status Scale EDSS Equine Digit Support System EDSS Executive Decision Support System EDSS Equipment Deployment and Storage System EDSS Electronic Document Storage System EDSS Electronic Data Storage System EDSS Electronic Document Submission System ) of 2.3 vs. 3.3 (p=0.011) from MSCRG baseline; * Lower disability progression to EDSS milestones four (64% vs. 83%, p=0.06), six (32% vs. 62%, p=0.008) and seven (9% vs. 33%, p=0.008); * Greater quality of life as measured by the physical component score of the SF-36 (p<0.0001); * Significantly greater sense of independence in self care (p=0.0019); and * Significantly more independent living (p=0.031). ASSURANCE was an open-label, retrospective, patient-reported, multicenter, 15-year follow-up study that included patients with relapsing MS who received 2 years of treatment in the pivotal Phase III trial (n=172). One hundred thirty-six of a possible 172 patients enrolled in the study. Patients were categorized as current AVONEX users and non-AVONEX users. Forty-six percent of those patients were currently taking AVONEX, with median treatment duration of 13.3 years. Patients not currently on AVONEX were treated with a number of other disease-modifying therapies, with 24 percent of patients undergoing treatment with TYSABRI([R]) (natalizumab). "This level of impact on disability and quality of life over the course of 15 years reinforces the real-life benefits and proven clinical effectiveness of AVONEX," said Thorsten Eickenhorst, MD, Vice President of Global Medical Affairs, Biogen Idec. "We pride ourselves on providing a treatment that is not only efficacious now but will continue to offer patients the support they need for as long as possible." 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 in Europe in 1997 for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX has been proven effective in clinical trials for up to three years. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for patients who have their first clinical MS attack and have a brain MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. scan consistent with MS; this use was approved in Europe in 2002 and in the U.S. in 2003. The most common side effects Side effects Effects of a proposed project on other parts of the firm. associated with AVONEX multiple sclerosis treatment are flu-like symptoms, including myalgia myalgia /my·al·gia/ (mi-al´jah) muscular pain.myal´gic epidemic myalgia see under pleurodynia. my·al·gia n. , fever, fatigue, headache, chills, nausea, vomiting, pain, and asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness. neurocirculatory 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 anaphylaxis (ăn'əfəlăk`sĭs), hypersensitive state that may develop after introduction of a foreign protein or other antigen into the body tissues. have been reported. For more information, visit www.AVONEX.com About Biogen Idec Biogen Idec creates new standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com. |
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