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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2024

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At a glance

  • Drugs Olezarsen (Primary)
  • Indications Hyperlipoproteinaemia type I
  • Focus Registrational; Therapeutic Use
  • Acronyms BALANCE
  • Sponsors Ionis Pharmaceuticals

    • Most Recent Events

    • 25 Jun 2024 According to an Ionis Pharmaceuticals Media Release, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for olezarsen, the PDUFA date by which FDA has set to an action is date of December 19, 2024.
    • 08 Apr 2024 Preliminary results assessing efficacy of olezarsen, presented at the 73rd Annual Scientific Session of the American College of Cardiology.
    • 07 Apr 2024 According to an Ionis Pharmaceuticals Media Release, company will host webcast on Monday, April 8 at 10:00 am ET t to discuss the detailed results from the Balance study.
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