Baxter盐酸艾考糊精透析液.ppt

CARDIO-RENALAdvisory Committee Meeting EXTRANEAL? (7.5% Icodextrin) Peritoneal Dialysis Solution NDA 21-321 Orphan Drug Designation 97-1056 August 9, 2001 Baxter Healthcare Corporation Baxter Participants Marsha Wolfson, M.D. Vice President, Global Clinical Affairs Salim Mujais, M.D. Vice President, Global Medical Affairs Frank Ogrinc, Ph.D. Clinical Statistician Leo Martis, Ph.D. Vice President, Solution Development James Moberly, Ph.D. Director, Solutions RD Richard Newman, Ph.D. Vice President, Global Product Development Mary Kay Rybicki Associate Director, Regulatory Affairs Consultants John Burkart, M.D. Professor of Internal Medicine/Nephrology, Bowman Gray School of Medicine Allan Collins, M.D. Professor of Medicine, University of Minnesota, Director Nephrology Analytical Services, Minneapolis Medical Research Foundation Marc DeBroe, M.D., Ph.D. Dept. of Nephrology Hypertension, University Hospital of Antwerp Ram Gokal, M.D. Consultant Nephrologist, University of Manchester Karl Nolph, M.D. Curator Professor Emeritus, University of Missouri, Columbia William Frishman, M.D. Chairman Professor of Medicine, New York Medical College, Department of Medicine Peter O’Brien, Ph.D. Professor of Biostatistics, Mayo Medical School, Department of Health Sciences Research Robert Stern, M.D. Carl J. Herzog Professor of Dermatology, Beth Israel Deaconess Medical Center Jeff Trotter, M.M. President, Ovation Research Group Extraneal Development Milestones First market approval UK 1992 by ML Labs Licensed by Baxter 1996 Marketing approval in 31 countries ~8200 patients currently treated worldwide 30% of PD patients in Europe US clinical trials began 1997 Orphan Drug designation granted 1997 NDA submitted December 2000 Proposed Indication Extraneal is indicated for a single daily exchange for the long (8-16 hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of chronic renal fail