A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy
Phase of Trial: Phase II/III
Latest Information Update: 05 Oct 2017
At a glance
- Drugs Volanesorsen (Primary)
- Indications Lipodystrophy
- Focus Therapeutic Use
- Acronyms BROADEN
- Sponsors Ionis Pharmaceuticals
- 27 Jul 2017 According to a company media release, Akcea plans to file for marketing authorization for volanesorsen to treat familial partial lipodystrophy (FPL) in 2019 if the data from the BROADEN study are positive.
- 25 Apr 2017 Planned primary completion date changed from 1 Sep 2017 to 30 Sep 2017.
- 19 Dec 2016 According to an Akcea Therapeutics media release, company plans to have data from this study in 2019.