CI-1 Certican ® (everolimus) Cardiovascular and Renal Drugs Advisory Committee Meeting November 16, 2005.

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Presentation transcript:

CI-1 Certican ® (everolimus) Cardiovascular and Renal Drugs Advisory Committee Meeting November 16, 2005

CI-2 Certican ® (everolimus) Introduction and Regulatory Background Mathias Hukkelhoven, PhD Senior Vice President Global Head, Drug Regulatory Affairs Novartis Pharmaceuticals Corporation

CI-3 Certican ® Clinical Development Program  Most comprehensive clinical development program in transplantation –25 trials (1 heart, 7 kidney, 17 clin-pharm) Approximately 3000 patients enrolled, 1800 patients treated 220 investigators worldwide  Phase 3 heart study B253 –634 patients –Follow-up at 6, 12, 24, and 48 months 122-5

CI-4 Certican ® Long-term Studies in Heart and Kidney de novo N = 2532 HeartB253 N = 634 6, 12, 24 months full-dose Neoral ® Open-label extension through 48 months KidneyB201, B251, B157 N = , 12, 36 months full-dose Neoral KidneyB351 N = 19 Pediatric full-dose Neoral 12, 24 months KidneyB156 N = 111 Full vs reduced-dose Neoral plus Simulect ® 12, 36 months KidneyA2306 N = 237 Reduced-dose Neoral: everolimus TDM 6, 12 months KidneyA2307 N = 256 Reduced-dose Neoral plus Simulect: everolimus TDM 6, 12 months

CI-5 Certican ® Global Registration Total country approvals in kidney and heart patients on commercial drug 75% are heart transplant patients Sweden reference state—kidney and heart approvalsJul 2003 Recommended approvals by 15 of 17 EU member states Dec 2003 Approval by 10 new EU member statesDec 2004 Australia, South Africa, Switzerland, South America (9), Central America (6), Israel Japan—new drug application submitted—heartJun countries have not approved Certican— Canada, Ireland, United Kingdom

CI-6 Certican ® NDA History NDA submissions in kidney and heart Dec 02 Oct 03 Approvable letter #1 for kidney and heart Approvable letter #2 for kidney and heart Aug 04 Feb 04Mar 05 Major amendment in support of AC discussions Nov 04 End-of-review meeting Response

CI-7 Overall Objectives  Review the primary efficacy and safety data from the Certican ® (everolimus) pivotal study in heart transplantation (B253)  Provide dosing recommendations for everolimus in combination with Neoral ®  Present data that support a favorable benefit-risk profile for everolimus in heart transplantation

CI-8 Certican ® Proposed Indication  Certican ® (everolimus) is indicated for the prophylaxis of organ rejection in adult patients receiving a heart transplant  It is recommended that Certican be used concurrently with Neoral ® and corticosteroids

CI-9 Certican ® Proposed Dosage and Administration  The pivotal heart study evaluated fixed doses of everolimus at 1.5 mg per day and 3.0 mg per day  Initial dose regimen of 1.5 mg per day in 2 divided doses (BID) adjusted to target trough level of 3 to 8 ng/mL  Certican should be used with reduced doses of cyclosporine after the first month

CI-10 Today’s Agenda Introduction and Regulatory background Mathias Hukkelhoven, PhD Challenges and Opportunities In Cardiac Transplantation Howard J. Eisen, MD Efficacy Results (B253)Jeffrey Hosenpud, MD IVUS Results (B253)Jon A. Kobashigawa, MD SafetyKenneth A. Somberg, MD Renal Safety and Dose Recommendations Lawrence Hunsicker, MD Benefit/Risk AssessmentHoward J. Eisen, MD

CI-11 Novartis Consultants Randall C. Starling, MD, MPhHead, Section of Heart Failure and Cardiac Transplant Medicine Department of Cardiovascular Medicine, Cleveland Clinic Foundation Cleveland, Ohio Lee-Jen Wei, PhDProfessor of Biostatistics Department of Biostatistics Harvard School of Public Health Boston, MA Hans B. Lehmkuhl, MDSenior Consultant Head of Heart and Lung Failure and Thoracic Transplantation German Heart Center Berlin, Germany