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Chugai
submitted Actemra in rheumatoid arthritis and a severe form of juvenile
arthritis for approval in Japan
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Basel,
28 April 2006
Roche announced today that Chugai has filed Actemra
with the Japanese Ministry of Health, Labour and
Welfare (MHLW) for two additional indications: rheumatoid
arthritis (RA) in adults and a devastating form
of arthritis in children known as systemic onset
juvenile idiopathic arthritis (sJIA). The filing
follows impressive results from the Phase III programme
in RA in Japan showing Actemra’s use as a first
line biologic and superiority over conventional
disease modifying anti-rheumatic drugs (DMARDs)
in monotherapy, as well as promising data in children
with sJIA. Actemra is currently registered in Japan
for the treatment of Castleman’s disease.
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Monoclonal antibody - new treatment option
for RA
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“This is a
significant milestone for Actemra which takes us a step closer
in Japan to easing the symptoms of this debilitating disease.
We look forward to the outcome of the large Phase III programme
currently being conducted outside Japan where Actemra is being
studied in several different patient populations of more than
4000 patients, over half of whom have already been enrolled in
the various studies” commented Eduard Holdener, Head of Roche
Global Pharma Development.
Strong results in Phase III trials
Today’s regulatory filing follows significant Phase III results
from rheumatoid arthritis trials in Japan where Actemra monotherapy
proved to be more efficacious than existing DMARDs in patients
who have an inadequate response to DMARD therapy. Dramatic improvement
of signs and symptoms of RA were achieved with American College
of Rheumatology (ACR1) scores
in the Prevention of Joint Damage (PJD) study – percentages of
Actemra patients achieving ACR20, 50 and 70 were 89%, 70% and
47% compared to 35%, 14% and 6% respectively in the DMARDs group
as well as in the Signs and Symptoms (S&S) study – percentage
of Actemra patients achieving ACR20, 50 and 70 were 80%, 49% and
29% compared to 25%, 11% and 6% respectively in the control arm.
Furthermore, patients receiving Actemra in the PJD study showed
significantly less radiographic joint destruction compared to
patients in the DMARDs control group (p=0.001). Actemra has been
shown to be generally well tolerated. New results from a Phase
III study conducted in Japan in sJIA patients will support the
filing submission for this pediatric indication. This data has
been submitted for presentation at an upcoming international medical
meeting.
About Actemra
Actemra (tocilizumab) is a new humanized anti-human interleukin-6
(IL-6) receptor monoclonal antibody whose novel mechanism of action
provides a new and effective form of treatment for RA. It aims
to become a major new therapeutic option for the treatment of
RA, a disease with a high unmet medical need. Roche and Chugai
have initiated a collaborative phase III clinical development
programme in RA which is underway outside Japan with more than
4000 patients expected to be enrolled in 41 countries including
several European countries and the USA.
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 leading to loss of
function. 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. RA
affects more than 21 million people worldwide with approximately
2 million people affected in Europe. In Japan it is estimated
that approximately 330,000 patients are treated for rheumatoid
arthritis.
About systemic juvenile idiopathic arthritis
Systemic onset juvenile idiopathic arthritis (sJIA) is a severe
disorder, which can have a devastating effect on children, sometimes
progressing to a fatal disease. Elevated serum IL-6 is thought
to play an important role in the clinical signs and symptoms of
this disease. sJIA occurs in about 10% to 20% of children with
juvenile inflammatory arthritis, with a prevalence of approximately
16 per 100,000 children.
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
disease, 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 medicines for cancer and
transplantation and a market leader in virology. In 2005 sales
by the Pharmaceuticals Division totalled 27.3 billion Swiss francs,
and the Diagnostics Division posted sales of 8.2 billion Swiss
francs. Roche employs roughly 70,000 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 (http://www.roche.com/).
All trademarks used or mentioned
in this release are legally protected.
Further information
- Chugai Pharmaceutical Co.
References:
1 The ACR response is a standard assessment used to measure
patients’ responses to anti-rheumatic therapies, devised by the
American College of Rheumatology (ACR). It requires a patient
to have a defined percentage reduction in a number of symptoms
and measures of their disease. For example, a 20 or 50% level
of reduction (the percentage of reduction of RA symptoms) is represented
as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for
existing treatments and represents a significant improvement in
a patient’s condition.
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