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
Latest Information Update: 30 Jan 2023
At a glance
- Drugs Volanesorsen (Primary)
- Indications Hypertriglyceridaemia; Lipodystrophy
- Focus Registrational; Therapeutic Use
- Acronyms BROADEN
- Sponsors Akcea Therapeutics; Ionis Pharmaceuticals
- 28 Jan 2023 This trial was completed in Italy according to European Clinical Trials Database
- 01 Dec 2022 According to a PTC Therapeutics media release, the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), has approved Waylivra (volanesorsen) as the first treatment for familial partial lipodystrophy (FPL) in Brazil.
- 21 Sep 2021 Status changed from active, no longer recruiting to discontinued.