EMA unit backs new hep C drugs Exviera and Viekirax from AbbVie

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a marketing authorization for US pharma company AbbVie’s (NYSE: ABBV) Exviera (dasabuvir) and Viekirax (ombitasvir + paritaprevir + ritonavir) for the treatment of chronic hepatitis C virus (HCV) infection in adults in combination with other medicinal products for the treatment of chronic hepatitis C.

HCV infection is a major European public health challenge, the Agency said. It affects between 0.4% and 3.5% of the population in different European Union member states and is the most common single cause of liver transplantation in the EU.

Exviera and Viekirax belong to a new generation of medicines for chronic HCV infection that have high cure rates and have recently reshaped the way this disease is treated. Both Exviera and Viekirax block the action of proteins which are essential for HCV replication. Exviera targets the protein NS5B while Viekirax targets the proteins NS5A and NS3/4A. A final decision is expected in the first quarter of 2015.