Omapatrilat in the treatment of hypertension
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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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Omapatrilat in the treatment of hypertension

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


Regulatory history

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


Presentation overview

Presentation Overview

  • Efficacy

    • Superior efficacy in monotherapy

    • Superior efficacy as the basis for a regimen

  • Safety

    • Incremental risk of angioedema

  • Benefit / Risk Considerations


Maximize benefit and manage the risk

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


Omapatrilat target population

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


Consultants

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


Agenda

Agenda

  • Clinical Efficacy Data ElliottLevy, M.D.

  • Angioedema:Clinical Overview AllenKaplan, M.D.

  • Clinical Safety Data Benefit / Risk Consideration ElliottLevy, M.D.

  • OVERTUREMilton Packer, M.D.

  • Clinician’s Perspective Henry Black, M.D.

  • ConclusionAnthony Waclawski, Ph.D.

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