Roche announced that the
Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA)
by a near unanimous (10-1) vote recommended approval of ACTEMRA(R)
(tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal
antibody, for reducing the signs and symptoms in adults with moderate to
severe rheumatoid arthritis (RA).
"The committee's overwhelmingly positive recommendation brings ACTEMRA
one step closer to becoming available to patients who suffer from the
painful and debilitating symptoms associated with RA," said Kenneth Bahrt,
M.D., Global Medical Director, Autoimmunity, Roche. "Based on the strength
of the data presented, and the positive recommendation by the committee, we
are hopeful that the FDA will approve ACTEMRA for the treatment of RA and
provide a new option to patients who are not achieving adequate symptom
relief with current therapies."
The committee's vote was made after Roche presented results from five
Phase III clinical trials. The clinical development program was designed to
evaluate the effects of ACTEMRA on signs and symptoms of RA, physical
function, progression of structural damage, and health-related quality of
life. Of these five studies, three trials were conducted in patients with
inadequate response to disease modifying anti-rheumatic drugs (DMARDs), one
trial was conducted in patients who failed anti-tumor necrosis factor (TNF)
therapy, and one monotherapy study comparing ACTEMRA to methotrexate, a
current standard of care, was also conducted. Results of these studies
demonstrated that treatment with ACTEMRA -- alone or in combination with
methotrexate or other DMARDs -- significantly reduced RA signs and
symptoms, regardless of previous therapy or disease severity, compared with
current DMARDs.
About ACTEMRA (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting
monoclonal antibody. Studies suggest that reducing the activity of IL-6,
one of several key cytokines involved in the inflammatory process, may
reduce inflammation of the joints and relieve certain systemic effects of
RA. The extensive clinical development program conducted by Roche includes
five clinical studies and has enrolled more than 4,000 patients in 41
countries, including the United States. Five Phase III studies are
completed and have reported meeting their primary endpoints. The LITHE
trial evaluating ACTEMRA in RA is an ongoing two-year study and is expected
to report complete data evaluating the effects of ACTEMRA on the inhibition
of structural joint damage in 2009. ACTEMRA is awaiting approval in the
United States and Europe.
ACTEMRA is part of a co-development agreement with Chugai, a Japanese
company. In June 2005, ACTEMRA was launched by Chugai in Japan as a therapy
for Castleman's disease; in April 2008, additional indications for
rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset
juvenile idiopathic arthritis were also approved in Japan.
The serious adverse events reported in ACTEMRA clinical trials include
serious infections, diverticular perforations, and hypersensitivity
reactions including anaphylaxis. The most common adverse events reported in
clinical trials were upper respiratory tract infection, nasopharyngitis,
headache and hypertension. Increases in liver function tests (ALT and AST)
were seen in some patients; these increases were generally mild and
reversible, with no hepatic injuries or any observed impact on liver
function. Laboratory changes, including increases in lipids (total
cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and
platelets, were seen in some patients without association with clinical
outcomes.
About IL-6
IL-6 is a common protein found in all joints in the body and is a
natural substance that can raise inflammation. Everyone has IL-6 in their
body, but people with RA may have too much. If approved, ACTEMRA will be
the first and only medication to specifically target IL-6 in patients with
RA.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the 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 that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, decreased hemoglobin, osteoporosis
and may contribute to shortening life expectancy by affecting major organ
systems. After 10 years, less than 50 percent of patients can continue to
work or function normally on a daily basis. RA affects more than 21 million
people worldwide with approximately 1.3 million adults affected in the
United States.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2007 Roche was named
Top Company of the Year by Med Ad News, one of the Top 20 Employers
(Science) and ranked the No. 1 Company to Sell For (Selling Power). In
previous years, Roche has been named as a Top Company for Older Workers
(AARP) and one of the Best Companies to Work For in America (Fortune). For
additional information about the U.S. pharmaceuticals business, visit our
website: rocheusa. Product and treatment information for
U.S. healthcare professionals is available at RocheExchange.
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