EC approves AbbVie's Viekirax + Exviera for hepatitis C

16 January 2015

The European Commission has granted marketing authorizations for US drugmaker AbbVie’s (NYSE: ABBV) all-oral, short-course, interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets).

The treatment has been approved with or without ribavirin (RBV) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients. Additionally, Viekirax has been approved for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.

Peak sales estimates for AbbVie’s hepatitis C drugs, which will compete with Gilead Sciences’ (Nasdaq: GILD) Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and) are in the range of $3 billion. Sovaldi has already reached mega-blockbuster status, generating sales of $8.5 billion in the first nine months of this year.

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