September 9, 2003
Source: Karisma Communications
Based on landmark clinical trial results, today's Health Canada approval could mean new hope for Canadians at high risk of developing multiple sclerosis.
Following closely on the heels of the FDA, Canadian authorities have now approved Biogen, Inc.'s Avonex® (interferon beta-1a) to delay the onset of MS - in people who have experienced their first MS-associated clinical attack - accompanied by abnormal brain MRI scans.
Until now, standard practice has been to define and treat MS only after patients experience repeated MS attacks, or relapses. Often, following repeated attacks, patients¹ MS disease status can worsen. Health Canada¹s approval means people with the first MS-associated clinical attack can now start Avonex without having to wait until more MS attacks occur.
"This new indication, based on research from the well-conducted CHAMPS trial (CHAMPS--Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study), is a significant advance in delaying this debilitating condition that negatively affects the lives of 50,000 Canadians," says Dr. Paul O¹Connor, neurologist and Director of the St. Michael¹s Hospital MS Clinic in Toronto, ON, as well as an investigator in the CHAMPS trial. "Physicians can now consider initiating therapy with Avonex at the first signs and symptoms of MS, rather than waiting until the disease has further progressed."
"This study provides more evidence that early treatment of MS can have a positive impact, " says Dr. William J. McIlroy, national medical advisor, Multiple Sclerosis Society of Canada.
Results of the CHAMPS Trial
The primary endpoint of the CHAMPS study, which was published in the New England Journal of Medicine (NEJM 2000; 343:898-904), was the time to development of clinically definite MS in patients who were considered at high risk of developing MS. These patients had recently experienced an isolated MS-associated event such as difficulties with vision, band numbness around the chest or abdomen, and/or the temporary loss of control of body movement, and nervous system lesions typical of MS visible on brain MRI scans.
Avonex significantly decreased by 44% the rate at which these patients developed a second attack compared with patients taking placebo. This was also accompanied by a highly significant reduction of MS brain lesions, considered to be another disease indicator, as seen on brain MRI scans. The incidence of neutralizing antibodies remained low at less than 2% throughout the study.
The CHAMPS study was a randomized, double blind, placebocontrolled clinical trial involving 383 patients who were considered at high risk of developing MS because they had recently experienced their first isolated demyelinating event and they had nervous system lesions typical of MS visible on brain MRI scans. Study participants received either 30 mcg of Avonex or placebo by intramuscular injection once weekly. There were eight Canadian trial sites, enrolling more than 100 patients, in this North American study.
Additional Data on Delaying Brain Atrophy and Cognitive Dysfunction in the Avonex Label
In addition to the new indication for Avonex, the product monograph now also mentions the effect of Avonex in delaying cognitive dysfunction and brain atrophy in patients with relapsing forms of MS. Data from further analysis on a subgroup of patients who completed the two years of the pivotal study showed that, compared to placebo controls, Avonex-treated patients had delayed worsening in brain atrophy, as well as Information Processing/Memory and on the Paced Auditory Serial Addition Test a standard test used to measure elements of cognitive function.
Avonex has been available in Canada for the treatment of Relapsing Remitting MS since 1998.
Multiple sclerosis is the most common neurological condition affecting young adults in Canada. MS most often strikes young adults women and men between 20 and 40 who are in their productive family and career years.
Biogen is the world's oldest independent biotechnology company and a leader in biologics research, development and manufacturing. A pioneer in leading edge research in immunology, neurobiology and oncology, Biogen brings novel therapies to improve patients' lives around the world through its global marketing capabilities.
Avonex® is a registered trademark of Biogen Inc.
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