Amgen 2002 Annual Report Download - page 21

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Page 19
a wide range of people with varying degrees of rheumatoid arthritis symptoms, from
recently diagnosed adults with moderate pain to individuals who have struggled with
severe symptoms for many years.
ENBREL
®
is approved for use to improve physical function, inhibit the progression of
structural damage, and reduce the signs and symptoms of moderately to severely active
rheumatoid arthritis in adult patients. It is also approved for use in reducing the signs
and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid
arthritis in patients four years to 17 years old who have had an inadequate response to
disease-modifying antirheumatic drugs.
More recently, ENBREL
®
has been approved for reducing the signs and symptoms of active
arthritis in patients with psoriatic arthritis, a chronic inflammatory disease characterized by
both joint and skin manifestations. ENBREL
®
currently has the broadest range of indications
of any biologic therapy in rheumatic diseases. Additional applications
to expand its treatment uses have been filed with the U.S. Food and
Drug Administration (FDA).
At the end of 2002, more than 80,000 people were taking ENBREL
®
, a
number that had been limited by manufacturing constraints. Increasing
production of the innovative therapeutic has been a key goal for Amgen
since acquiring Immunex in July 2002. In December 2002, Amgen
received approval from the FDA for its ENBREL
®
manufacturing facility
in Rhode Island, making new supplies of ENBREL
®
available.
Amgen and Wyeth Pharmaceuticals, Amgen’s North American
marketing partner for ENBREL
®
, last fall initiated a follow-on clinical
trial of the innovative therapeutic that is the largest such study of its kind.
The new study is evaluating the impact of ENBREL
®
in comparison to
other antirheumatic therapies using a population of 10,000 rheumatoid
arthritis patients in the United States.
Kineret
®
(anakinra) is a recombinant form of a naturally occurring human
protein that regulates interleukin-1 (IL-1), another key cytokine in
regulating normal immune function and the cascade of reactions that
cause the inflammatory process of rheumatoid arthritis and similar
diseases. Kineret
®
binds to the same cellular receptors as IL-1 without
activating those receptors, and thus neutralizes their harmful effects.
Kineret
®
is an important therapeutic option for the reduction in signs and symptoms
of rheumatoid arthritis in adult patients who have had an inadequate response to disease-
modifying antirheumatic drugs. The therapeutic is currently approved for use in the United
States, Europe, and Canada.
Amgen clinical researchers continue to study the impact of Kineret
®
on disease progression
in rheumatoid arthritis, including its ability to inhibit bone and joint damage.