7asdf Omapatrilat in the Treatment of Hypertension NDA 21-188 FDA Cardiovascular and Renal Drugs Advisory Committee Meeting July 19, 2002 Anthony Waclawski,

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Presentation transcript:

7asdf Omapatrilat in the Treatment of Hypertension NDA FDA Cardiovascular and Renal Drugs Advisory Committee Meeting July 19, 2002 Anthony Waclawski, Ph.D. Director, Regulatory Sciences Pharmaceutical Research Institute

A-2 Regulatory History December 1999 December 1999 –NDA for the treatment of hypertension submitted April 2000 April 2000 –BMS withdrew the NDA August 2000 August 2000 –OCTAVE study initiated December 2001 December 2001 –BMS resubmitted the NDA for omapatrilat for the treatment of hypertension

A-3 Presentation Overview Efficacy Efficacy –Superior efficacy in monotherapy –Superior efficacy as the basis for a regimen Safety Safety –Incremental risk of angioedema Benefit / Risk Considerations Benefit / Risk Considerations

A-4 Risk Management Program Risk of Angioedema Superior Efficacy Maximize Benefit and Manage the Risk Patients with increased cardiovascular risk and hypertension that is difficult to control Patients with increased cardiovascular risk and hypertension that is difficult to control Target Use of Omapatrilat to Patients Most Likely to Benefit Identification of risk factors Identification of risk factors Education to minimize the risk of life-threatening angioedema Education to minimize the risk of life-threatening angioedema

A-5 Omapatrilat Target Population Patients with: A high risk of major cardiovascular events* A high risk of major cardiovascular events* –Cardiovascular disease (e.g., MI, CHF) –Target organ damage (e.g., LVH, proteinuria) –3 or more cardiovascular risk factors –Diabetes or renal disease and and Hypertension that is difficult to control with existing medications Hypertension that is difficult to control with existing medications *Based on WHO-ISH guidelines Use with special caution in black patients and current smokers

A-6 Consultants College of Medicine State University of New York Health Science Center Brooklyn, NY James D. Neaton, Ph.D. School of Public Health University of Minnesota Minneapolis, MN Milton Packer, M.D., FACC Columbia University College of Physicians and Surgeons Columbia Presbyterian Medical Center New York, NY Michael A. Weber, M.D., FACP, FACC Henry Black, M.D., FACP Rush Medical College, Rush University Rush-Presbyterian-St. Luke’s Medical Center Chicago, IL Charles Hennekens, M.D., Ph.D. University of Miami School of Medicine Miami, FL Allen Kaplan, M.D. Medical University of South Carolina Charleston, SC

A-7 Agenda Clinical Efficacy Data Elliott Levy, M.D. Angioedema: Clinical Overview Allen Kaplan, M.D. Clinical Safety Data Benefit / Risk Consideration Elliott Levy, M.D. OVERTURE Milton Packer, M.D. Clinician’s Perspective Henry Black, M.D. Conclusion Anthony Waclawski, Ph.D..……………………….....………... …... ……...……… ………... ………………………...