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Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

Trial Profile

Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

Discontinued
Phase of Trial: Phase IV

Latest Information Update: 26 Dec 2018

At a glance

  • Drugs Celiprolol (Primary)
  • Indications Ehlers-Danlos syndrome
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 26 Dec 2018 According to an Acer Therapeutics media release, based on this trial, the company is advancing EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS).The U.S. FDA has accepted the New Drug Application (NDA) of EDSIVO for review, for the treatment of vEDS in patients with a confirmed type III collagen (COL3A1) mutation. The FDA also granted a priority review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of 25th Jun 2019.
    • 07 Mar 2018 According to an Acer Therapeutics media release, a pre-NDA meeting with the FDA is planned in the second quarter of 2018.
    • 25 Sep 2017 According to an Acer Therapeutics media release, company plans to file an NDA for celiprolol (EDSIVO) for the treatment of vascular Ehlers-Danlos Syndrome (vEDS) in the first half of 2018, and data from this trial, which was verified by an Acer-sponsored retrospective source will be utilised to support the application.
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