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U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
Date:4/8/2008

- ORENCIA is a First-in-Class Biologic Treatment Option Now Available for

Use in Pediatric Patients with JIA(1,2) -

PRINCETON, N.J., April 8, 2008 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved ORENCIA(R) (abatacept) for reducing signs and symptoms in pediatric patients six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). ORENCIA should not be administered concomitantly with tumor necrosis factor (TNF) antagonists and is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra. This new indication for ORENCIA provides significant evidence of its durable efficacy and long-term safety in pediatric patients, including those initiating biologic therapy for the first time. The safety and efficacy of ORENCIA in JIA were assessed in a three-part study through one year. The approval of ORENCIA in JIA represents the ongoing commitment of Bristol-Myers Squibb in this therapeutic area.

"In a JIA clinical trial, ORENCIA provided meaningful and sustained improvements in this patient population across three major sub-types of JIA through one year," said Edward H. Giannini, M.Sc., Dr.P.H., Professor of Pediatrics, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, OH.

The approval is based on the AWAKEN (Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment) trial, which evaluated the efficacy and safety of ORENCIA(R) (abatacept) in
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SOURCE Bristol-Myers Squibb Company
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