AbbVie receives US regulatory approval for Mavyret
Pharmaceutical Technology | September 27, 2019
AbbVie has received the US Food and Drug Administration (FDA) approval for Mavyret (glecaprevir / pibrentasvir) to lower the therapy period from 12 to eight weeks in hepatitis C (HCV) patients with cirrhosis. The indication for once-daily therapy is meant for treatment-naïve, compensated cirrhotic, chronic HCV patients across all genotypes (GT1-6). Previously, the drug secured FDA approval in August 2017 for eight-week, pan-genotypic therapy for treatment-naïve HCV patients without cirrhosis. Mavyret is a ribavirin-free medication that consists of 100mg glecaprevir in combination with 40mg pibrentasvir. Glecaprevir is an NS3 / 4A protease inhibitor, while pibrentasvir inhibits NS5A. AbbVie discovered glecaprevir as part of its ongoing alliance with Enanta Pharmaceuticals, which focuses on HCV protease inhibitors and regimens, including protease inhibitors.