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labeling update for Orencia for rheumatoid arthritis
April 28, 2007
Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug
Administration (FDA) has approved an update to the ORENCIA® (abatacept)
product labeling regarding the progression of structural joint damage
-- an important measure in the treatment of rheumatoid arthritis (RA).
The indication was strengthened from “slowing” to “inhibiting” the
progression of structural da mage in adult patients with moderately to
severely active RA who have had an inadequate response to one or more
disease-modifying, anti-rheumatic drugs (DMARDs), such as methotrexate
(MTX) or tumor necrosis factor (TNF) antagonists.
is indicated for reducing signs and symptoms, inducing major clinical
response, inhibiting the progression of structural da mage, and
improving physical function in adults with moderately to severely
active RA who have had an inadequate response to one or more DMARDs,
such as methotrexate or TNF antagonists. ORENCIA may be used as
monotherapy or concomitantly with DMARDs other than TNF antagonists.
ORENCIA should not be administered concomitantly with TNF antagonists
and is not recommended for use concomitantly with anakinra.
ORENCIA, which was first approved on
December 23, 2005, is a selective co-stimulation modulator of a signal
required for full T-cell activation and works in a fundamentally
different way than cytokine antagonists, including TNF antagonists.
labeling change is supported by two-year radiographic data from the
Phase III AIM (Abatacept in Inadequate responders to MTX) trial, which
met the co-primary endpoints of ACR 20 scores at six months, Health
Assessment Questionnaire Disability Index (HAQ-DI) scores at one year
and joint Erosion Scores (ES) at one year. Fifty-six percent of
ORENCIA® (abatacept)/MTX-treated patients had no progression during the
first year compared to 45 percent of placebo/MTX-treated patients. In
the open-label extension period of the study, 75 percent of patients
initially randomized to ORENCIA and MTX and 65 percent of patients
initially randomized to placebo and MTX were evaluated radiographically
at Year 2. Progression of structural da mage in ORENCIA/MTX-treated
patients was further reduced in the second year of treatment. Following
two years of treatment with ORENCIA/MTX, 51 percent of patients had no
progression of structural da mage as defined by a change in the
Genant-Modified Total Sharp Score (TSS) of zero or less compared with
baseline. More than half of patients on ORENCIA had no radiographic
progression in either Year 1 or Year 2 (56 percent and 65 percent,
(Last updated on Saturday, , and first posted on Friday, April 27,
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