AbbVie has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its investigational regimen of glecaprevir/pibrentasvir to treat all major genotypes of the chronic hepatitis C virus (HCV).
AbbVie has submitted the NDA based on 8 registrational studies in its glecaprevir/pibrentasvir clinical development program. More than 2300 patients in 27 countries across major HCV genotypes were evaluated. The patient population included:
- Genotypes 1-6
- Treatment-naive and experienced to treatment
- Without cirrhosis and compensated cirrhosis
- With severe chronic kidney disease
- Not cured with prior direct-acting antiviral (DAA) agents
Data from the registrational studies showed that 97.5% of patients (n = 693/711) with chronic HCV genotypes 1-6 without cirrhosis achieved sustained virologic response (SVR) at 8 weeks. Those new to treatment achieved SVR at 12 weeks. Headache and fatigue were the most common adverse events reported in this group.
In a primary intent-to-treat analysis, 98% of patients (n = 102/104) with chronic kidney disease also achieved SVR at 12 weeks. Pruritus, fatigue, and nausea were the most common adverse events reported in patients with chronic kidney disease.
Based on the positive results from the phase 2 MAGELLAN-1 study (ClinicalTrials.gov Identifier: NCT02441283), the glecaprevir/pibrentasvir regimen was granted breakthrough therapy designation by the FDA on September 30, 2016. This designation was granted for the “treatment of patients with HCV who were not cured with prior direct-acting antiviral (DAA) therapy in genotype 1, including therapy with an NS5A inhibitor and/or protease inhibitor.”
AbbVie will be submitting a Marketing Authorization Application for glecaprevir/pibrentasvir in the European Union in early 2017.
AbbVie submits new drug application to U.S. FDA for its investigational regimen of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes of chronic hepatitis C [press release]. North Chicago, IL: AbbVie Inc. Published December 19, 2016. Accessed January 3, 2017.