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http://www.pslgroup.com/dg/5bac2.htm Rebif Approved And Launched In Canada TORONTO, ON -- February 18, 1998 -- Health Canada has granted approval for Serono Canada's beta 1 a, Rebif(R), indicated to delay disease progression in patients with relapsing remitting multiple sclerosis (RRMS) in two dosing options (22 mcg and 44 mcg three times per week), thus allowing optimisation of treatment. The product's higher dose is required for those MS patients considered significantly disabled. Rebif is the first therapy to be proven effective in all major outcome parameters: delaying progression to disability; reducing the number and severity of relapses (exacerbations); and reducing disease activity (lesions), as measured by Magnetic Resonance Imaging (MRI) scans. Unlike other disease modifying drugs used for the treatment of MS, Rebif is available in a ready-to-use, pre-filled, liquid syringe that can be injected subcutaneously; it requires no reconstitution of powders. "This study demonstrates, for the first time, effectiveness on all major outcomes of the disease," said Mark Freedman, M.D., associate professor of medicine, Ottawa General Hospital, and a lead PRISMS (Prevention of Relapses and Disability by Interferon-beta-1a, Subcutaneously in Multiple Sclerosis) investigator. "Moreover, it provides compelling clinical and MRI data at two doses, showing a dose-related effect." The basis for this approval was a pivotal trial, PRISMS, conducted in 22 centres in nine countries, including Canada. It is the largest-ever controlled clinical trial completed in the field of MS and studied the highest dose of beta interferon in a phase III trial. In this double-blind, randomised study, 560 MS patients took 22 and 44 mcg doses of Rebif or a placebo three times a week for two years. Participants' clinical status was monitored every three months and magnetic resonance imaging (MRI) scans were conducted twice a year. The PRISMS study found that both doses of Rebif slowed the progression of disability, with the time to confirmed progression increasing from 11.8 months for patients on placebo to 18.2 and 21 months for patients treated with Rebif at 22 and 44 mcg, respectively. In addition, the overall disability experience, assessed using the Integrated Disability Status Scale (IDSS(1)), was reduced by 83 percent at two years. The trial showed effectiveness in delaying the progression to disability in patients considered functionally impaired (EDSS(2) less than 3.5). The higher dose of Rebif (44 mcg three times per week) is also the first treatment proven effective in delaying progression to disability in patients considered significantly disabled (EDSS greater than 3.5). At both doses, treatment with Rebif led to a significant reduction in the number of exacerbations (29 percent and 32 percent, at 22 and 44 mcg doses, respectively) and the proportion of patients remaining exacerbation-free approximately doubled. Both doses increased the number of exacerbation-free patients, prolonged time to first exacerbation and second exacerbation and reduced the number of patients who experienced moderate to severe exacerbations. Both the 22 and 44 mcg doses dramatically reduced disease activity (as defined by new or enlarging lesions, and Gadolinium enhancement). Treatment with Rebif also resulted in a decrease in burden of disease, or the volume of brain affected by disease, while patients on placebo experienced a marked increase. Rebif is a genetically-engineered interferon-beta produced in mammalian host cells (Chinese hamster ovary cells). Interferon beta 1a has the same antiviral and antiproliferative properties as the naturally-occurring protein, which will make it better tolerated than alternative therapies. MS is a chronic, progressive disease of the central nervous system associated with periods of disability alternating with periods of recovery. The disease attacks the myelin sheath, the nerve fibre insulation which speeds up the transmission of messages between the CNS and the rest of the body, thereby disrupting the natural flow of impulses. Persons with MS suffer a number of symptoms including impaired vision, spasticity, tingling and paralysis, and may gradually become physically debilitated. Canada has one of the highest rates of MS in the world, with approximately 50,000 Canadians suffering from the condition. In patients with relapsing remitting MS, the disease follows an ongoing series of attacks or exacerbations, and partial recoveries or remissions. RRMS is distinguished by the unpredictable occurrence of the new symptoms or the worsening of old ones. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved. Judith Richards [log in to unmask]