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Basel, 6 September 2005
Roche files first rheumatoid
arthritis indication for MabThera in Europe
MabThera delivers significant and sustained
relief from symptoms in patients with difficult-to-treat rheumatoid arthritis
This
filing follows positive results from the REFLEX study which showed that MabThera is highly effective
in relieving symptoms in patients who have had an inadequate response or are intolerant to prior treatment
with one or more anti-TNF (biologic) therapies. Most important, the benefits are seen after only a short
treatment course of two infusions.
RA is one of the most common forms
of autoimmune disease which affects more than 21 million people worldwide, with up to 2 million sufferers
in Europe alone. Of the RA patients treated with current biologic therapy, about 30% do not have a satisfactory
outcome and at present have few treatment alternatives remaining. There is therefore a high need for
novel and effective options for patients whose daily life continues to be impacted by this serious disease.
"MabThera offers a unique new treatment for patients with rheumatoid
arthritis in that it selectively targets B cells, providing a fundamentally different approach for managing
painful and swollen arthritic joints. A successful regulatory outcome will allow physicians and patients
an alternative option for tackling this debilitating disease" commented Eduard Holdener, Head of
Global Pharma Development in Roche’s Pharmaceutical Division.
Today’s
regulatory filing of MabThera for patients with the most difficult-to-treat RA is to support the first
indication of MabThera in rheumatoid arthritis and marks the beginning of a new opportunity for Roche
in this therapeutic area. Genentech and Biogen Idec have also recently submitted a US filing for Rituxan
(rituximab’s name in the US).
MabThera has a strong heritage in the treatment
of a form of lymphatic cancer called non-Hodgkin’s lymphoma (NHL) where over 730,000 patients have been
treated with MabThera to date.
About the REFLEX study
The
REFLEX study (Randomised Evaluation oF Long-term Efficacy of Rituximab in RA) is a multi-centre, randomized,
double-blind, placebo-controlled Phase III study. In this trial, patients who received a single course
of only two infusions of MabThera with a stable dose of methotrexate (MTX) displayed a statistically
significant improvement in symptoms measured at 24 weeks, compared to those receiving placebo and MTX.
A preliminary analysis of the REFLEX data did not reveal any unexpected safety signals and the companies
continue to monitor the long-term safety of MabThera in all clinical trials. The results of the REFLEX
trial will be presented at the American College of Rheumatology meeting in San Diego in November.
About
MabThera
MabThera is a therapeutic antibody that selectively targets B cells without
affecting stem, pro-B or plasma cells, therefore allowing continuation of normal protective function.
B cells play a key role in the inflammatory cascade of RA and MabThera aims to break this inflammatory
cascade - a series of reactions inflaming the synovia and leading to cartilage loss and bone erosion
that is characteristic of the disease. MabThera has also been studied in a Phase IIb study, DANCER (Dose-Ranging
Assessment iNternational Clinical Evaluation of Rituximab in RA), which was designed to evaluate the
efficacy and safety of varying doses of MabThera in combination with MTX in patients with active RA
who currently have an inadequate response to MTX.
About
Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune
disease characterized by inflammation of the membrane lining in joints. This inflammation causes a loss
of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible
joint destruction and disability. Characteristics of RA include redness, swelling, pain, and movement
limitation around joints of the hands, feet, elbows, knees and neck. In more severe cases of RA the
eyes, lungs or blood vessels may be involved. RA may also shorten life expectancy by affecting major
organ systems and after 10 years, less than 50% of patients can continue to work or function normally
on a day to day basis.
About Roche
Headquartered
in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the
fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the
early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range
of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics,
the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2004
sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division
posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has
R&D agreements and strategic alliances with numerous partners, including majority ownership interests
in Genentech and Chugai. Additional information about the Roche Group is available on the Internet.
All trademarks used or mentioned in this release are
legally protected.
Further information
-
Genentech
- Biogen Idec |
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MabThera: a medicine used to treat non-Hodgkin's lymphoma
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