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