A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)
Phase of Trial: Phase III
Latest Information Update: 20 Sep 2017
At a glance
- Drugs Glecaprevir/pibrentasvir (Primary)
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ENDURANCE-2
- Sponsors AbbVie
- 28 Jul 2017 According to an Enanta Pharmaceuticals media release, the European Commission (EC) granted AbbVie marketing authorization for MAVIRET (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). The approval of MAVIRET is supported by data from eight registrational studies in AbbVie's clinical development program.
- 23 Jun 2017 According to an Enanta Pharmaceuticals media release, the MAA evaluation is conducted under the European Union's centralized licensing procedure, and if approved will result in a marketing authorization valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
- 23 Jun 2017 According to an Enanta Pharmaceuticals media release, based on the data from SURVEYOR-I, SURVEYOR-II, EXPEDITION-4, ENDURANCE-1, ENDURANCE-2, ENDURANCE 3 and ENDURANCE-4 trials, the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET for treatment for adults with chronic hepatitis C virus infection. Final decision is expected in the third quarter of 2017.