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ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
Date:8/19/2007

NEW YORK, Aug. 7 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the supplemental biologics license application (sBLA) for ORENCIA(R) (abatacept) for the treatment of pediatric patients with juvenile idiopathic arthritis (JIA) 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.

This sBLA is based on data from a double-blind, randomized trial that consisted of three periods: a four-month open-label lead-in treatment period in which all participants (6-17 years old) received ORENCIA and both clinical response and safety were assessed (Period A), a six-month randomized double- blind withdrawal phase in which responders received either ORENCIA or placebo and time to disease flare and safety were assessed (Period B), and an open- label phase in which all participants received ORENCIA in order to assess long-term efficacy and safety (Period C).

ORENCIA, which was discovered and developed by Bristol-Myers Squibb, is currently approved for use in adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more DMARDs such as MTX or TNF antagonists. ORENCIA is a selective modulator of a co- stimulatory signal required for full T-cell activation.

About Juvenile Idiopathic Arthritis

JIA -- also commonly known as juvenile rheumatoid arthritis (JRA) -- is a chronic, autoimmune disease, causing chronic pain, stiffness and swelling of the joints, which may ultimately lead to joint damage and deformities. The disease usually begins be
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SOURCE Bristol-Myers Squibb Company

Copyright©2007 PR Newswire.

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