Pharmaceutical Business review

AbbVie secures European approval to market VIEKIRAX + EXVIERA to treat HCV

The combination has been approved with or without ribavirin (RBV) for these patients, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.

In addition, the EC has approved VIEKIRAX for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.

AbbVie chairman of the board and chief executive officer Richard Gonzalez said: "The approval of AbbVie’s hepatitis C treatment in the European Union, following the recent approvals in the US and Canada, offers patients across Europe a new and effective treatment to cure this serious disease.

"We are committed to working with local governments and healthcare systems to support broad access to VIEKIRAX + EXVIERA."

The treatment is currently licensed for use in all 28 member countries of the EU, as well as in the US, Canada, Switzerland, Iceland, Liechtenstein and Norway.

The company said that VIEKIRAX + EXVIERA are the first products to be approved as a combination treatment of three direct-acting antivirals with distinct mechanisms of action targeting hepatitis c at multiple steps in the viral lifecycle.

AbbVie executive vice president, Research and Development and chief scientific officer Michael Severino said: "With the approval of VIEKIRAX + EXVIERA in the European Union, we are offering a treatment that achieved high cure rates for people living with GT1 and GT4 chronic hepatitis C."