AbbVie submits New Drug Application for Hepatitis C treatment

These studies considered a pool of over 2,300 patients throughout 27 countries over all of the major HCV genotypes.
These studies considered a pool of over 2,300 patients throughout 27 countries over all of the major HCV genotypes. | File photo
The U.S. Food and Drug Association is reviewing AbbieVie's New Drug Application (NDA) for a new treatment of Hepatitis C virus. 
The FDA both accepted AbbVie's NDA and gave the biopharmaceutical company priority review for the investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), a treatment that is being evaluated for the treatment of Hepatitis C virus (HCV). 
The NDA submitted by AbbVie has been backed by eight registrational studies from the company's G/P clinical development program. These studies considered a pool of over 2,300 patients throughout 27 countries over all of the major HCV genotypes and accounted 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," Executive Vice President of Research and Development and Chief Scientific Officer Dr. Michael Severine said.
The FDA gives priority review designation to the medications which it deems may have the ability to treat certain diseases.