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| |  Avonex Cleared by FDA for Relapsing Forms of Multiple Sclerosis CAMBRIDGE, Mass., May 17, 1996 -- Biogen, Inc. (Nasdaq: BGEN) today announced that it has received a license from the U.S. Food and Drug Administration (FDA) to market AVONEX(TM) (Interferon beta-1a), a new drug for treatment of relapsing forms of multiple sclerosis (MS). AVONEX(TM) is the first and only therapy shown in a pivotal clinical trial to both slow the accumulation of physical disability and decrease the frequency of clinical exacerbations in relapsing MS. In addition, AVONEX(TM) requires a once-a-week intramuscular injection. This may be more convenient than the every-other-day injections required with the currently available therapy for MS. "The availability of AVONEX(TM) is important for patients because it may alter the fundamental course of relapsing MS," said Lawrence D. Jacobs, M.D., the lead investigator for the AVONEX(TM) (Interferon beta-1a) Phase III trial. Dr. Jacobs is professor of neurology at the State University of New York at Buffalo, head of neurology at the Buffalo General Hospital and Chief of the Baird Multiple Sclerosis Center at the Millard Fillmore Hospital in Buffalo. "AVONEX(TM) offers new hope to MS patients because it is the first therapy to show in a blinded clinical trial that it can actually slow the accumulation of disability while also reducing the frequency of neurological attacks." AVONEX(TM) will be available by prescription on Monday, May 20. Biogen has sufficient supply available to treat all patients who receive prescriptions. AVONEX(TM) is administered intramuscularly at a dose of 30 micrograms (mcg) once a week. AVONEX(TM) is intended for use under the guidance and supervision of a physician. Patients may self-inject AVONEX(TM) if their physician determines that it is appropriate after proper training in intramuscular injection technique and with medical follow-up as necessary. Biogen will make AVONEX(TM) available through traditional wholesaler channels. Biogen will sell a four-week supply of AVONEX(TM) to wholesalers for $710 (wholesaler acquisition cost). The actual price to patients will vary based on retail mark-up and health plan coverage. The company has developed a comprehensive set of optional services to make starting and continuing therapy easier for both physicians and patients. In addition to making the drug available through traditional pharmacy outlets, Biogen offers special pharmacy and home delivery options that provide assignment of benefits (direct billing of patients' health plans). The company also offers reimbursement counseling for all potential patients and an injection training program for those patients who will self-inject AVONEX(TM). Information about AVONEX(TM) and all these service programs is available through a single toll-free number for the AVONEX(TM) Support Line -- 1-800-456-2255. "We are pleased to introduce AVONEX(TM) as the first drug the company will market under the Biogen name," said Jim Vincent, Biogen's chief executive officer. "The licensing of this new drug represents the culmination of nearly 15 years of research, and we are proud to offer an effective, well-tolerated and convenient treatment for relapsing MS patients." Applications for marketing authorization of AVONEX(TM) have also been filed in Europe, Canada, Australia and New Zealand. AVONEX(TM) Clinical Profile In a Phase III, randomized, double-blind, placebo-controlled, multi-center trial in patients with relapsing MS, the AVONEX(TM)-treated group experienced a 37 percent reduction in the risk of clinically significant disability progression, compared to the placebo group. Clinically significant progression in disability was defined as an increase of one or more points on the Expanded Disability Status Scale (EDSS), sustained for at least six months. The EDSS is the standard tool used in clinical trials for evaluating disability progression in MS. In addition, AVONEX(TM)-treated patients had significantly less frequent exacerbations, compared to the placebo group. For example, 14 percent of the AVONEX(TM)-treated patients had three or more exacerbations over the course of two years, compared to 32 percent of patients in the placebo group. AVONEX(TM)-treated patients also had a statistically significant reduction in the number and volume of active brain lesions identified on gadolinium-enhanced Magnetic Resonance Imaging (MRI) studies, compared to placebo patients. The exact relationship between MRI findings and the clinical status of patients is unknown. AVONEX(TM) (Interferon beta-1a) treatment was well-tolerated; four percent of patients treated with AVONEX(TM) in the pivotal clinical trial discontinued taking the drug due to adverse events. Side effects seen in the trial were modest. The most common side effects associated with AVONEX(TM) were flu-like symptoms, muscle ache, fever, chills and asthenia (weakness). Most patients experienced at least one of these symptoms on at least one occasion during the study. However, the incidence of these symptoms diminished with continued treatment. In addition, injection-site reactions associated with AVONEX(TM) treatment occurred in only four percent of patients (not significantly different from patients in the placebo group). No injection-site skin necrosis was observed in any of the MS patients. The safety and efficacy of AVONEX(TM) in patients with chronic-progressive MS have not been studied. This clinical study was conducted at five sites: Buffalo General Hospital, The Cleveland Clinic Foundation, Georgetown University Medical Center (Washington, D.C.), Legacy Good Samaritan Hospital (Portland, Ore.) and Walter Reed Army Medical Center (Washington, D.C.). Multiple Sclerosis MS is a chronic, inflammatory disease of the central nervous system (CNS) in which most patients incur disability over time. MS affects approximately 250,000 people in the United States, two-thirds of whom are women. Disease onset typically occurs in young adults between the ages of 20 and 40. The disease is believed to be caused by the destruction of myelin by the immune system. Myelin is the fatty tissue that surrounds and protects CNS nerve fibers and facilitates the flow of nerve impulses to and from the brain. The loss of myelin disrupts the conduction of nerve impulses, producing the symptoms of MS. Disease symptoms vary substantially from patient to patient. However, common symptoms include weakness, numbness, fatigue, vision problems, slurred speech, poor coordination, short-term memory loss, depression, and bowel or bladder dysfunction. Severe cases of MS can be characterized by partial or complete paralysis. Although the course of MS is unpredictable and highly variable among patients, MS patients generally fit one of two disease classifications, depending on the predominant course of the disease. Individuals with relapses (exacerbations or discrete attacks of neurological symptoms), followed by complete or incomplete recovery, have a relapsing form of the disease. Slow, inconsistent accumulation of disability also occurs in the majority of these patients. In the initial stages of the disease, 85-90% of individuals with MS have relapsing disease. Individuals with a steady progression of disability and few or no exacerbations have a progressive form of MS. This form includes individuals who have progressive disease from onset (10-15%) and those who eventually convert from relapsing MS (30-40%). Within the total MS population at any given time, approximately 50% have relapsing MS and approximately 50% have progressive MS. "The MS community welcomes the introduction of AVONEX(TM)," said Stephen C. Reingold, Ph.D., Vice President, Research and Medical Programs, National Multiple Sclerosis Society. "Clinical data have shown that it has an impact on disability progression with a reduction in relapses and a favorable safety profile. This product offers a new treatment option for individuals with relapsing forms of MS." AVONEX(TM) (Interferon beta-1a) should be used with caution in patients with depression and patients with seizure disorders. AVONEX(TM) should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Routine, periodic blood chemistry and hematology tests are recommended during treatment with AVONEX(TM). Please see the full prescribing information (provided in the press kit). Biogen, Inc., headquartered in Cambridge, Mass., is a biopharmaceutical company principally engaged in developing and manufacturing drugs for human healthcare through genetic engineering. The Company's revenues are generated from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products. Biogen is focused primarily on developing and testing products for the treatment of MS, inflammatory and respiratory diseases, and certain viruses and cancers. To obtain a video news release (VNR) about AVONEX(TM) (Interferon beta-1a): call Tierney Kennedy at 312-942-1199, ext. 187. To obtain an audio news release (ANR) about AVONEX(TM): call 800-746-3863.
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