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Omapatrilat in the Treatment of Hypertension

Omapatrilat in the Treatment of Hypertension. NDA 21-188. Anthony Waclawski, Ph.D. Director, Regulatory Sciences Pharmaceutical Research Institute. 7asdf. FDA Cardiovascular and Renal Drugs Advisory Committee Meeting July 19, 2002. Regulatory History. December 1999

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Omapatrilat in the Treatment of Hypertension

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  1. Omapatrilat in the Treatmentof Hypertension NDA 21-188 Anthony Waclawski, Ph.D.Director, Regulatory SciencesPharmaceutical Research Institute 7asdf • FDA Cardiovascular and Renal DrugsAdvisory Committee Meeting • July 19, 2002

  2. Regulatory History • December 1999 • NDA for the treatment of hypertensionsubmitted • April 2000 • BMS withdrew the NDA • August 2000 • OCTAVE study initiated • December 2001 • BMS resubmitted the NDA for omapatrilatfor the treatment of hypertension

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

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

  5. Omapatrilat Target Population • Patients with: • 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 • Hypertension that is difficult to controlwith existing medications Use with special caution in black patientsand current smokers *Based on WHO-ISH guidelines

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

  7. Agenda • Clinical Efficacy Data ElliottLevy, M.D. • Angioedema:Clinical Overview AllenKaplan, M.D. • Clinical Safety Data Benefit / Risk Consideration ElliottLevy, M.D. • OVERTURE Milton Packer, M.D. • Clinician’s Perspective Henry Black, M.D. • Conclusion Anthony Waclawski, Ph.D. ......………... ……...………... …... ………………………... ..………... .………………………...

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