The FDA has accepted AbbVie’s New Drug Application (NDA) for and granted priority review to its investigational, pan-genotype regimen of glecaprevir/pibrentasvir (G/P).
The FDA has accepted AbbVie’s New Drug Application (NDA) for and granted priority review to its investigational, pan-genotype regimen of glecaprevir/pibrentasvir (G/P). The treatment is being evaluated for its ability to treat all major genotypes (GT1-6) of chronic hepatitis C virus (HCV).
The NDA is based on data from 8 studies which evaluated more than 2300 patients in 27 countries across all major HCV genotypes and special populations.
G/P is a once-daily regimen that combines 2 distinct antiviral agents in a fixed-dose combination of glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor. It is designed to be a potential cure in 8 weeks for patients with HCV without cirrhosis and who are new to treatment.
“We are pleased that G/P has been granted priority review by the FDA,” said AbbVie executive vice president Michael Severino, MD, in a press release. “We will continue to work closely with the agency as they review our New Drug Application and we remain committed to bringing a new cure to patients with chronic hepatitis C.”
US FDA Grants Priority Review to Abbvie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) [news release]. AbbVie’s website. https://news.abbvie.com/news/us-fda-grants-priority-review-to-abbvie-for-its-investigational-regimen-glecaprevirpibrentasvir-gp-for-treatment-chronic-hepatitis-c-in-all-major-genotypes-gt1-6.htm. Accessed Feb 3, 2017.