Posted by Michael Wonder on 25 Jul 2016
CHMP grants positive opinion for shorter treatment duration with AbbVie's Viekirax (ombitasvir/paritaprevir/ritonavir tablets) for patients with genotype 4 chronic hepatitis C with compensated cirrhosis (Child-Pugh A)
25 July 2016 - The CHMP opinion represents a positive advance toward approval of the 12-week regimen of Viekirax with ribavirin for genotype 4 chronic hepatitis C virus infected adult patients with or without compensated cirrhosis.
AbbVie announced today that the European CHMP of the EMA has granted a positive opinion for the use of 12 weeks of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin in genotype 4 chronic hepatitis C virus infected adult patients with compensated cirrhosis (Child-Pugh A). Viekirax with ribavirin is currently approved in the European Union for GT4 patients with compensated cirrhosis for 24 weeks.
"Through optimizing the use of Viekirax, AbbVie strives to meet the needs of patients and physicians, including a shortened treatment duration," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone is progress toward an approval that would allow us to provide the opportunity for a cure with just 12 weeks of our regimen to genotype 4 patients with or without compensated cirrhosis in Europe."
