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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

nancy registry has been established to monitor fetal outcomes. Healthcare professionals are encouraged to register pregnant patients exposed to ORENCIA by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (three percent ORENCIA vs. 1.9 percent placebo) and malignancies (1.3 percent ORENCIA vs. 1.1 percent placebo). In general, adverse events in pediatric and adolescent patients were similar in frequency and type to those seen in adult patients.

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA(R) (abatacept) or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2 percent) than those on placebo (zero percent). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (greater than or equal to 10 percent): Headache, upper respiratory tract infection, nasopharyngitis and nausea were the most commonly reported adverse events in the adult RA clinical studies.

Please see accompanying Full Prescribing Information or visit http://www.ORENCIA.com or http://www.BMS.com.

About ORENCIA

ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA is also indicated for reducing signs and symptoms in pediatric patients aged six years and older with moderately to severely active polyarticular JIA. ORENCIA may
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SOURCE Bristol-Myers Squibb Company
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