Regimen of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C GT1-6: FDA has granted priority review
The FDA ( U.S. Food and Drug Administration ) has accepted New Drug Application ( NDA ) and granted priority review for the investigational, pan-genotypic regimen of Glecaprevir and Pibrentasvir ( G/P ), for the treatment of all major genotypes ( GT1-6 ) of chronic hepatitis C virus ( HCV ).
The FDA grants priority review designation to medicines that it determines have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease.
The NDA is supported by data from eight registrational studies in Glecaprevir and Pibrentasvir clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and for special populations.
Glecaprevir and Pibrentasvir ( G/P ) clinical development Program was designed to investigate a faster path to virologic cure for all major HCV genotypes ( GT1-6 ) and with the goal of addressing treatment areas of continued unmet need.
Glecaprevir and Pibrentasvir is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients.
AbbVie is also studying Glecaprevir and Pibrentasvir in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease ( CKD ), including patients on dialysis.
Glecaprevir and Pibrentasvir is a once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of Glecaprevir ( 100mg ), an NS3/4A protease inhibitor, and Pibrentasvir ( 40mg ), an NS5A inhibitor.
Glecaprevir and Pibrentasvir ( 300/120mg ) is dosed once-daily as three oral tablets. ( Xagena )
Source: Abbvie, 2017