AVONEX(R), the #1 Prescribed Multiple Sclerosis (MS) Therapy Worldwide: New MRI Data Presented.CAMBRIDGE, Mass. -- Initial findings presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS ECTRIMS European Committee for Treatment and Research in Multiple Sclerosis ) in Madrid, Spain showed that treatment with AVONEX (Interferon beta-1a interferon beta-1a Avonex, Rebif Pharmacologic class: Biological response modifier Therapeutic class: Antiviral, immunoregulator Pregnancy risk category C Action) promoted a statistically significant recovery of T1-black hole lesion volume by almost 24% (p<0.05) in patients with RRMS RRMS Relapsing/Remitting Multiple SclerosisRRMS Rosemont Ridge Middle School (West Linn, Oregon) RRMS Rocky Run Middle School (Virginia) RRMS Recoverable Resource Management Services compared to baseline. Black holes are indicative of irreversible axonal axonal pertaining to or arising from an axon. axonal degeneration an axon dies and cannot be replaced if its cell body is destroyed. damage and correlate strongly with development of long-term disability in patients with MS. Furthermore, AVONEX showed a statistically significant improvement in measures of brain atrophy (9.7% [p<0.0001] decrease in lateral ventricular volume in patients with RRMS compared to baseline). The objective of this study was to evaluate the effect of AVONEX on global and focal disease as measured by multiple non-conventional and conventional MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. indices in a large sample of MS patients with either relapsing-remitting (RR) or secondary-progressive MS over 1 year. This study was an open label, single-blind, post-marketing, MRI observational study In statistics, the goal of an observational study is to draw inferences about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator. . 147 patients (131 with RRMS) were included with a mean pre-study disease duration of 11.1 years and followed for an average of 13.7 months. Patients received clinical and MRI examination at baseline and at the end of follow-up. "This study represents one of the largest non-conventional MRI studies ever performed in patients with MS," said Dr. Robert Zivadinov, Associate Professor of Neurology and Director of the Buffalo Neuroimaging and Analysis Center, part of the Jacobs Neurological Institute, SUNY SUNY - State University of New York Buffalo, NY. He emphasized, "that the positive effect of AVONEX was particularly evident in patients with RRMS." This cohort represents a well-defined group of patients being on AVONEX monotherapy for a mean of 4.0 years before study entry. This study was funded by a grant from Biogen Idec Biogen Idec, Inc. (NASDAQ: BIIB) is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen and San Diego, California-based Idec . About AVONEX AVONEX (Interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been established. AVONEX is the most prescribed treatment for relapsing forms of multiple sclerosis 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 disability and reduce relapses. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for MS patients who have their first clinical MS attack and have a brain MRI scan that suggests 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 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 in caution with 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. Please see complete prescribing information available at 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. |
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