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Efficacy and Safety of Epanova (Omefas) in Severe Hypertriglyceridemia.

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Trial Profile

Efficacy and Safety of Epanova (Omefas) in Severe Hypertriglyceridemia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Omega-3 carboxylic acids (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms EVOLVE
  • Sponsors AstraZeneca

    • Most Recent Events

    • 06 May 2014 According to an AstraZeneca media release, FDA approval was granted for Epanova based on data that included results from this trial.
    • 09 Jul 2013 Positive results from this trial are included in the NDA submission to the FDA for Epanova for the treatment of patients with very high triglyceride levels, according to an Omthera Pharmaceuticals media release.
    • 09 Nov 2012 Results were presented at the Scientific Sessions of the American Heart Association (AHA).

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