Omapatrilat in the Treatment of Hypertension

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

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Presentation Overview

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

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Maximize Benefit and Manage the Risk
Risk of Angioedema
Superior Efficacy
Risk Management Program
Target Use of Omapatrilat to Patients Most Likely
to Benefit

• Patients with increased cardiovascular risk and
  hypertension that is difficult to control

• Identification of risk factors
• Education to minimize the risk of
  life-threatening angioedema

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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
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Consultants
Michael A. Weber, M.D., FACP, FACC

• College of MedicineState University of New
  YorkHealth Science CenterBrooklyn, NY

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Agenda
Clinical Efficacy Data Elliott Levy,
M.D. AngioedemaClinical Overview Allen
Kaplan, M.D. Clinical Safety Data Benefit / Risk
Consideration Elliott Levy, M.D. OVERTURE Milton
Packer, M.D. Clinicians Perspective Henry
Black, M.D. Conclusion Anthony Waclawski, Ph.D.
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