May 15, 2002
PR Newswire - USA
Early treatment with AVONEX (after a first demyelinating event) reduces the risk of the next relapse by 63%* at 2 years in multiple sclerosis patients determined to be at high-risk**. AVONEX is the first and only disease-modifying multiple sclerosis medicine to possess this indication and for which the benefits of early treatment have been clearly established in a registered dosage.
Biogen France SA today announced that the European Commission has approved an indication extension for AVONEX 30(g once a week.
AVONEX is now indicated for the treatment of patients with a first demyelinating event*** if they are determined to be at high risk of developing Clinically Definite Multiple Sclerosis (CDMS). This approval follows the positive opinion given by the European Committee for Proprietary Medicinal Products (CPMP) in January.
The decision was based on data from the CHAMPS1 study (a), where patients were given AVONEX 30 (g, administered intramuscularly once a week, versus placebo, for up to three years. In a post-hoc sub-group analysis (b), high-risk patients** had a 2-year risk of suffering a second event of 56% in the placebo group and 21% in the AVONEX treatment group. This showed a 63% reduction in risk in this population of developing a second relapse.
The overall incidence of NABs in the CHAMPS study was 2% in the AVONEX group. (1)
Dr Mats Soderstrom, Associate Professor and Lecturer in Neuro-Ophthalmology at the Karolinska Institute, Stockholm, Sweden commented: 'This is an important development for patients and physicians. There is now considerable amounts of good, indirect proof that early treatment of high-risk patients has a long-term positive benefit. If these patients now remain untreated they may risk neurological damage.'
Independently from the European Commission decision, additional encouraging new data was presented at the recent American Academy of Neurologists meeting in Denver, concluding that AVONEX, with a low incidence of neutralising antibodies (NABs), shows sustained long term efficacy after four years of treatment (2).
AVONEX is the first and only disease-modifying drug to possess the first demyelinating event indication in high-risk patients and for which the benefits of early treatment have been clearly established in a registered dosage1. At the end of 2001, more than 118,000 patients were treated with AVONEX, which remains the number one therapy worldwide for patients with relapsing remitting multiple sclerosis.
The European Commission decision means that the indication extension is valid in all 15 Member States of the European Union as well as in Norway and Iceland. References and Editors' notes
AVONEX 30(g once a week is already registered for the treatment of relapsing remitting multiple sclerosis (i.e. after the second relapse) and has shown efficacy in reducing relapses by 32% over 2 years (p = 0.002) and the risk of sustained disability progression by 37% over 2 years (p=0.024). (3)
(a) CHAMPS study
The CHAMPS trial was originally conducted to determine whether AVONEX delays the development of CDMS in patients with a single demyelinating event who had MRI evidence of prior, sub-clinical disease. A total of 383 patients were randomised to receive AVONEX 30 (g (n=193) or placebo (n=190) IM once weekly.
The pivotal CHAMPS study shows that AVONEX provided a 44% overall reduction in the risk of second event compared to placebo (p=0.002). Not only was this effect observed within six months and sustained throughout the study, it was even stronger after adjusting for the age of the patients involved, the type of presenting demyelinating event, baseline lesion volume, and the presence of enhancing lesions at baseline (a 49% reduction, p<0.001).
(b) Sub group analysis
Ninety-one of 383 patients had high MRI lesion burden with evidence of inflammation, defined as the presence of at least 9 T2-hyperintense lesions and at least 1 gadolinium (Gd)-enhanced lesion on the initial (baseline) MRI scan. Fifty-one patients received AVONEX 30 (g and 40 patients received placebo IM once weekly. At 2 years, the Kaplan-Meier estimate of the cumulative probability of second event was 56% in the placebo group and 21% in the AVONEX group. Therefore, the reduction in risk of developing CDMS at 2 years was 63% in the AVONEX group, compared to the placebo group. Notes
1. Jacobs LD et al CHAMPS (Controlled High Risk Subjects AVONEX Multiple Sclerosis Prevention Study) New England Journal of Medicine 2000: 343; 898-904
2. Kappos L et al. Sustained efficacy of Interferon Beta-1a in relapsing Multiple Sclerosis: four-year results from the European dose comparison study. Neurology 2002; 58 (suppl 3): A460
3. Jacobs LD et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996; 39: 285-294
* 63% based on Kaplan Meier estimates of the cumulative probability of developing CDMS at 2 years: 21% Avonex, 56% Placebo.
** At least 9 T2 lesions and at least 1 Gd enhancing lesion at initial scan.
*** With an active inflammatory process if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded.
If you would like to interview Professor Soderstrom, please contact
either Nick Hicks at Biogen International +33 1 41 37 7051 or Abigail Huntington
at Lowe Fusion Healthcare +44 20 8948 0094
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