Wednesday March 6, 03:01 PM
AVONEX 30 Âµg once a week gives a 63% absolute reduction in risk of a second relapse occurring in patients at high risk of developing Clinically Definite Multiple Sclerosis. AVONEX would be the first disease-modifying drug (DMD) to possess this indication and the only treatment for which the benefits of early treatment have been clearly established in a registered dosage.
Paris - Biogen France SA announced today that the Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion recommending the grant of an indication extension for AVONEX 30 Âµg once a week in the treatment of patients who are at high risk of developing Clinically Definite Multiple Sclerosis (CDMS). If granted final marketing Authorisation by the European Commission, AVONEX will be the first disease-modifying drug to possess this indication and the only treatment for which the benefits of early treatment have been clearly established in a registered dosage. As a result of this, patients who previously may have suffered silent neurological damage before receiving DMD therapy could now receive help in this critical early phase.
AVONEX would in future be indicated for the treatment of certain patients who have experienced a single demyelinating event and have an active inflammatory process and if they are determined to be at high risk of developing CDMS. The CPMP decision was based on data from CHAMPS (1) (Controlled High Risk Subjects AVONEX Multiple Sclerosis Prevention Study) where patients were given AVONEX 30 Âµg administered intramuscularly once weekly for up to three years or placebo. In a post-hoc analysis, those patients with a baseline MRI with at least 1 Gd-enhancing lesion and 9 T2 lesions 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% absolute reduction in risk in this population of developing CDMS.
AVONEX 30 Âµg once a week is already registered for the treatment of relapsing remitting multiple sclerosis, a more advanced form of the condition and has shown long term efficacy in reducing relapses by 32% and reducing disability progression by 37%.(2) At the end of 2001, more than 118,000 patients were on AVONEX, which remains the number one therapy world-wide for patients with multiple sclerosis. CHAMPS also showed that AVONEX 30 Âµg significantly reduces the risk of disease progression by 44% compared to placebo (p=0.002) in the overall population.
Prior to this publication, there was no clinically demonstrated evidence to support the early use of disease modifying therapy in patients whose MRI scans had shown them to be at risk of disease progression. Interestingly, a study recently published by Brex et al in the New England Journal of Medicine suggested a potential long-term clinical benefit from therapies that suppress lesion formation in the early years of the disease. (3)
Dr Mats Soderstrom, Associate Professor and Lecturer in Neuro-Ophthalmology at the Karolinska Institute, Stockholm, Sweden commented: "This new indication will be of great benefit to patients. Even among specialists who support the use of beta-interferon in MS, the prevailing view has been to wait until clinical disease activity is well and truly established before starting AVONEX therapy. Doctors will be able to prevent the disease worsening in nearly two out of three of their high risk patients after they suffer a first relapse."
The recommendation of the CPMP serves as the basis for approval by the European Commission, which would extend the AVONEX indication in all 15 Member States of the European Union. The Commission typically issues its decision within three to four months of a positive CPMP opinion.
(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). Jacobs LD et al. intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39:285-294
(3). Brex P et al A Longitudinal Study of Abnormalities on MRI and disability from Multiple Sclerosis New England Journal of Medicine 2002:346; 158-164.
(i) 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 Âµg (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 disease progression 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).
(ii) 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 Âµg and 40 patients received placebo IM once weekly. At 2 years, the Kaplan-Meier estimate of the cumulative probability of developing CDMS was 21% in the AVONEX group, compared with 56% in the placebo group. Therefore, the absolute reduction in risk of developing CDMS at 2 years was 63 % in the AVONEX group compared with the placebo group (p=0.002).
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Wednesday March 6, 8:55 am Eastern Time
LONDON, March 6 (Reuters) - Biogen Inc (NasdaqNM:BGEN - news) said on Wednesday EU scientists had backed its top-selling multiple sclerosis drug Avonex for use in patients suffering the early stages of the wasting disease.
"As a result of this, patients who previously may have suffered silent neurological damage before receiving therapy could now receive help in this critical early phase," the U.S. company said in a statement issued by its Paris office.
The recommendation by scientists at the European Medicine Evaluation Agency still needs the approval of the European Commission.
Avonex is already approved for relapsing remitting multiple sclerosis, a more advanced form of the condition. The licence extension means it could in future also be prescribed to patients immediately after their first relapse.
Dr Mats Soderstrom, Associate Professor and Lecturer in Neuro-Ophthalmology at the Karolinska Institute, Stockholm, Sweden said in a company news release: "This new indication will be of great benefit to patients...Doctors will be able to prevent the disease worsening in nearly two out of three of their high risk patients after they suffer a first relapse."
Avonex sales were worth $249 million
in the final quarter of 2001. Biogen estimates that sales for the full
year will be worth $960-965 million.
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