Betaferon(R) Approved in Europe as a First-Line Treatment for the Earliest Stages of Multiple Sclerosis
June 07 2006 - 5:09AM
PR Newswire (US)
BERLIN, June 7 /PRNewswire-FirstCall/ -- Schering AG, Germany (FSE:
SCH, NYSE: SHR) announced today that Betaferon(R) (interferon
beta-1b) has been granted marketing authorization by the European
Commission for an extension of its indication to include the
treatment of patients with a first clinical event suggestive of
multiple sclerosis (MS) in all 25 European member states, as well
as Iceland and Norway. With this approval, Betaferon(R) becomes the
only high-dose high-frequency therapy approved for the treatment of
the earliest stages of MS. The approval provides an important
treatment option for patients to reduce the risk of developing
clinically definite MS (CDMS), and the chance to delay the
progression of the disease. The new label now allows for treatment
of the majority of patients at risk for MS, i.e., those with a
first clinical event (attack) suggestive of MS. "Effective
treatment early in the course of the disease is important since
studies have shown that irreversible nerve damage and brain atrophy
can occur in the earliest stages of MS. We now have the ability to
treat patients from the earliest sign of MS with therapy that has
an excellent safety profile over 16 years," said David Bates,
Professor of Clinical Neurology at the University of Newcastle upon
Tyne, UK, and Chairman of the MS Forum. The label extension is
based on results from the BENEFIT(a) study which showed that
Betaferon(R) 250 mcg treatment in the early phase of the disease
reduced the risk of developing CDMS by 50 percent compared with
placebo(1,b). Furthermore, patients in the Betaferon(R) group were
two times better protected(c) than placebo-treated patients against
developing MS as defined by the McDonald diagnostic criteria(2).
Left untreated in the placebo group, 85 percent of people who
experienced a first clinical event went on to be diagnosed with MS
within two years. "The results of the BENEFIT trial show that
Betaferon can substantially slow down the course of MS in early
patients, especially those at the earliest stage of the disease,
when it has the greatest impact," said Darlene Jody, MD, Head of
Specialized Therapeutics Global Business Unit at Schering Group. A
supplemental biologics license application (sBLA) requesting an
expanded label for Betaferon(R) (marketed as Betaseron(R) in the
U.S.) was filed with the U.S. Food and Drug Administration by
Berlex, Inc., a U.S. affiliate of Schering AG, in February 2006 and
is pending review. The Betaferon(R) extended indication is for the
treatment of patients with a single demyelinating event with an
active inflammatory process, if it is severe enough to warrant
treatment with intravenous corticosteroids, if alternative
diagnoses have been excluded, and if they are determined to be at
high risk of developing clinically definite multiple sclerosis. The
results of the BENEFIT study were used to define the high risk
criteria for identifying patients appropriate for Betaferon(R)
treatment. The criteria reflect the differences in disease
dissemination among patients with monofocal(d) and multifocal(d)
onset of disease with a first clinical event suggestive of MS.
Betaferon is also indicated for the treatment of: - Patients with
relapsing remitting MS and two or more relapses within the last two
years - Patients with secondary progressive MS with active disease,
evidenced by relapses. Footnotes (a) Betaferon(R)/Betaseron(R) in
Newly Emerging MS For Initial Treatment. (b) 50 Percent risk
reduction based on adjustment for a standard set of baseline
covariates. (c) At the end of the study period of two years. (d)
Monofocal onset of disease is where clinical findings are explained
by a single lesion in the central nervous system (CNS). Multifocal
onset of disease is where clinical findings are explained by at
least two underlying CNS lesions. References 1. L Kappos.
Betaferon(R) in Newly Emerging Multiple Sclerosis for Initial
Treatment (BENEFIT): clinical results. Presented at ECTRIMS/ACTRIMS
2005. 2. McDonald et al. Recommended Diagnostic Criteria for MS.
Ann Neurol 2001; 50:121-127. Additional information ABOUT BENEFIT
The multi-center, double-blind, randomized, phase III BENEFIT study
was conducted in 98 centers in 20 countries and included a total of
487 patients presenting with a single clinical episode suggestive
of MS. Patients with a first clinical demyelinating event
suggestive of MS and typical MRI findings received either eight
million units of interferon beta-1b (Betaferon(R)) every other day
or placebo as a subcutaneous injection. Treatment continued for up
to 24 months unless patients experienced a second attack and were
diagnosed with clinically definite MS. The two co-primary efficacy
outcomes were time to CDMS, based on a second clinical
demyelinating event or an Expanded Disability Status Scale (EDSS)
progression >=1.5 points, and time to MS according to the
McDonald criteria. All study participants completing the double
blind study were then invited to participate in a separate
open-label follow-up study with Betaferon(R) which will
prospectively assess the impact of such early treatment with
Betaferon(R) on the long-term course of the disease for a total
observation time of five years, including the impact of early
treatment on the formation of new brain lesions as measured by
magnetic resonance imaging (MRI). BENEFIT patients included those
who had a first clinical demyelinating event either monofocal (i.e.
clinical evidence of a single lesion) or multifocal (i.e. clinical
evidence of more than one lesion). Inclusion of both patient groups
is important because this is representative for the patient
population with a single event. ABOUT BETAFERON
Betaferon(R)/Betaseron(R) was the first disease-modifying drug
introduced for MS and is a well-established treatment around the
world. Betaferon(R) has the broadest experience of any MS
medication. In the US, Europe and Japan, Betaferon(R) has been
approved for all relapsing forms of MS. It is able to reduce the
number of MS episodes by one third, and the frequency of moderate
to severe episodes by as much as 50 percent. Sixteen years' follow
up of people treated with Betaferon has shown that it is safe and
well tolerated. Schering AG is a research-based pharmaceutical
company. Its activities are focused on four business areas:
Gynecology & Andrology, Oncology, Diagnostic Imaging as well as
Specialized Therapeutics for disabling diseases. As a global player
with innovative products Schering AG aims for leading positions in
specialized markets worldwide. With in-house R&D and supported
by an excellent global network of external partners, Schering AG is
securing a promising product pipeline. Using new ideas, Schering AG
aims to make a recognized contribution to medical progress and
strives to improve the quality of life: making medicine work This
press release has been published by Corporate Communication of
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+49-30-468-114-32, Find additional information at:
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