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Omapatrilat. Bristol-Myers Squibb.

R Tabrizchi1

  • 1Memorial University of Newfoundland, Faculty of Medicine, Basic Medical Sciences, Health Sciences Centre, St John's, Canada. rtabrizc@morgan.ucs.mun.ca

Current Opinion in Investigational Drugs (London, England : 2000)
|March 14, 2002
PubMed
Summary

Bristol-Myers Squibb is developing omapatrilat, a dual inhibitor of ACE and NEP, for cardiovascular diseases. Following an NDA withdrawal due to angioedema concerns, further studies are underway to assess its safety and efficacy for hypertension and heart failure.

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Area of Science:

  • Cardiovascular pharmacology
  • Drug development and regulatory affairs

Background:

  • Omapatrilat, a dual inhibitor of angiotensin-converting enzyme (ACE) and neutral endopeptidase (NEP), was under development by Bristol-Myers Squibb (BMS) for cardiovascular diseases.
  • The drug was intended for treating hypertension and heart failure.

Purpose of the Study:

  • To assess the efficacy and safety of omapatrilat compared to enalapril in hypertension treatment through the multinational OCTAVE trial.
  • To address concerns raised by the FDA regarding angioedema, an infrequent side effect, following the initial NDA filing.

Main Methods:

  • Phase III clinical trials for hypertension commenced by January 1998.
  • A multinational, 25,000-patient study (OCTAVE) was planned to compare omapatrilat with enalapril.
  • Prospective controlled clinical studies in patients with hypertension and heart failure were to continue.

Main Results:

  • BMS voluntarily withdrew the NDA in April 2000 due to FDA questions about angioedema incidence and severity.
  • Data analysis was anticipated in late summer/early autumn 2001, with expectations to refile the NDA.
  • The OCTAVE trial was expected to generate data by mid-2001, potentially allowing for an early 2002 launch.

Conclusions:

  • Further clinical studies were conducted to evaluate omapatrilat's safety and efficacy profile.
  • The refiling of the NDA was anticipated, with potential launch dates projected for 2002-2003.
  • Financial analysts projected significant peak sales for omapatrilat, indicating market expectations for the drug.

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