Physician Resources
Newly Available, Newly Approved
Am J Orthop. 2008 May;37(5):277
ORENCIA® (abatacept) Approved for Polyarticular JIA
| Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has approved ORENCIA® (abatacept) for reducing signs and symptoms in pediatric patients 6 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. Bristol-Myers Squibb notes that 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 3-part study through 1 year. 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® (abatacept) in patients 6 to 17 years of age with moderately to severely active polyarticular JIA who had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs), such as MTX or TNF antagonists. In addition to the approval for JIA, Bristol-Myers Squibb has added a postmarketing safety section to the package insert. The FDA has also revised the adult indication to remove the requirement that patients must first fail at least one DMARD before initiating therapy with ORENCIA. For more information on the new indication statement, visit Bristol-Myers Squibb |
Osteobiologics Line
| Integra LifeSciences Holdings Corporation has introduced the Integra OS™ Osteoconductive Scaffold and the Trel-X™ and Trel-XC™ Demineralized Bone Matrix products through the Integra Extremity Reconstruction division. Each product has received clearance from the US Food and Drug Administration. This new family of osteobiologic products comprises 3 distinct product lines: Integra OS™ Osteoconductive Scaffold, a synthetic bone void filler manufactured from beta tri-calcium phosphate and type I bovine collagen; Trel-X™, a demineralized bone matrix; and Trel-XC™, a demineralized bone matrix premixed with cancellous bone. Integra OS™ Osteoconductive Scaffold provides a 3-dimensional osteoconductive scaffold for new bone formation. The collagen portion of the matrix provides a binding site for the cells and proteins that are necessary for new bone deposition. The manufacturer notes that, when used in conjunction with patient-derived bone marrow, Integra OS™ Osteoconductive Scaffold may substitute for harvesting bone graft material from the patient’s iliac crest, thus sparing the patient additional surgery and postoperative pain. Trel-X™ Demineralized Bone Matrix is provided in a reverse-phase poloxamer carrier to provide exceptional handling characteristics and resistance to irrigation. Each lot of |