�Roche announced that the
Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA)
by a near unanimous (ci) 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 creaky arthritis (RA).
"The committee's overwhelmingly positive recommendation brings ACTEMRA
one step closer to becoming available to patients world Health Organization suffer from the
terrible 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 incontrovertible 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 tolerable symptom
relief with electric current therapies."
The committee's vote was made after Roche presented results from fivesome
Phase III clinical trials. The clinical development curriculum was designed to
judge the personal effects of ACTEMRA on signs and symptoms of RA, physical
subprogram, progression of structural harm, and health-related quality of
life. Of these five-spot studies, trey 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 mortification factor (TNF)
therapy, and one monotherapy study comparison ACTEMRA to methotrexate, a
current criterion of care, was besides conducted. Results of these studies
demonstrated that intervention with ACTEMRA -- solitary or in combination with
methotrexate or other DMARDs -- significantly reduced RA signs and
symptoms, careless of premature therapy or disease severeness, 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 various key cytokines involved in the incitive process, crataegus oxycantha
reduce inflaming of the joints and relieve certain systemic effects of
RA. The all-embracing clinical development program conducted by Roche includes
five-spot clinical studies and has enrolled more than than 4,000 patients in 41
countries, including the United States. Five Phase III studies ar
completed and have reported meeting their primary endpoints. The LITHE
trial evaluating ACTEMRA in RA is an ongoing two-year cogitation and is expected
to report make out data evaluating the effects of ACTEMRA on the inhibition
of structural articulation damage in 2009. ACTEMRA is awaiting approval in the
United States and Europe.
ACTEMRA is section of a co-development understanding 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, puerile idiopathic arthritis and systemic-onset
juvenile idiopathic arthritis were also approved in Japan.
The good adverse events reported in ACTEMRA clinical trials include
serious infections, diverticular perforations, and hypersensitivity
reactions including anaphylaxis. The most
