AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for glecaprevir/pibrentasvir (G/P). G/P is the company’s investigational combination therapy regimen for the treatment of all major genotypes of the chronic hepatitis C virus (HCV). The once-daily, orally-administered therapy includes two distinct antiviral agents in a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. The therapy regimen, which is designed to last eight weeks, does not include ribavirin.
The FDA grants Priority Review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. According to an AbbiVie press release, the NDA is supported by data from eight 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. If approved G/P could help patients without cirrhosis and across all major genotypes, to achieve a sustained virological response (SVR). SVR signifies that a patient has “cleared” the virus when the viral load is reduced to undetectable levels in the bloodstream.
“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, MD, executive vice president, research and development and chief scientific officer at AbbVie.
Source: AbbVie press release dated February 2, 2017
