AbbVie, a global biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated 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 AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and for special populations.

"We are pleased that G/P has been granted priority review by the FDA. 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," said Michael Severino, managing director, executive vice president, research and development and chief scientific officer, AbbVie.

AbbVie's glecaprevir/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.

G/P 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 G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.

G/P 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. G/P (300/120mg) is dosed once-daily as three oral tablets.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.