25 April 2016 - AbbVie today announced that the FDA has approved a supplemental new drug application for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).

The application was previously granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness.

On 26 February 2016 AbbVie announced that the European CHMP of the EMA granted a positive opinion for Viekirax (ombitasvir/ paritaprevir/ ritonavir tablets) + Exviera (dasabuvir tablets) and this RBV-free option is now approved for use for the treatment of chronic HCV infected GT1b patients with compensated cirrhosis (Child-Pugh A) in Europe.

For more details, go to: https://news.abbvie.com/news/abbvie-receives-us-fda-approval-supplemental-new-drug-application-for-viekira-pak-ombitasvir-paritaprevir-and-ritonavir-tablets-dasabuvir-tablets-without-ribavirin-in-genotype-1b-chronic-hepatitis-c-patients-with-compensated-cirrhosis.htm