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A Phase III pivotal registrational trial of Vascepa® (icosapent ethyl) capsules in a patient population with severe hypertriglyceridemia

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Trial Profile

A Phase III pivotal registrational trial of Vascepa® (icosapent ethyl) capsules in a patient population with severe hypertriglyceridemia

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2023

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At a glance

  • Drugs Ethyl eicosapentaenoic acid (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Amarin Corporation

    • Most Recent Events

    • 01 Jun 2023 According to an Amarin Corporation media release, the company has received regulatory approval for VASCEPA from China's National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (=500 mg/dL).
    • 09 Feb 2021 According to an Amarin Corporation the Chinese National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for VASCEPA. Company anticipates receiving a decision in Mainland China near the end of 2021.
    • 19 Nov 2020 According to an Amarin Corporation media release, Amarin intends to support Edding in its pursuit of an appropriate label for VASCEPA in China reflecting the results of this study and all other available data supporting the safety and efficacy of VASCEPA.
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