FDA OKs New Use for AbbVie’s Hepatitis C Drug
The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the use of AbbVie’s Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) 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.
Viekira Pak is a prescription medicine used with or without RBV to treat adults with genotype 1 (GT1) chronic (lasting a long time) HCV infection, and can be used in people who have a certain type of cirrhosis (compensated).
In February 2016, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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.