European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX + EXVIERA

20-Jan-2015 - USA

AbbVie announced that the European Commission has granted marketing authorizations for its 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.

"The approval of AbbVie's hepatitis C treatment in the European Union, following the recent approvals in the U.S. and Canada, offers patients across Europe a new and effective treatment to cure this serious disease," said Richard Gonzalez, chairman of the board and chief executive officer, AbbVie. "We are committed to working with local governments and healthcare systems to support broad access to VIEKIRAX + EXVIERA."

The approvals follow a review under accelerated assessment by the European Medicines Agency, designated to new medicines of major public health interest. Approximately nine million people in Europe are infected with chronic hepatitis C, a major cause of liver cancer and liver transplantation Genotype 1 is the most prevalent form of hepatitis C in Europe, accounting for 60 percent of cases worldwide. In Europe, the most prevalent sub-genotype is 1b (47 percent). Genotype 4, most common in the Middle East, sub-Saharan Africa and Egypt, is becoming increasingly prevalent in several European countries, including Italy, France, Greece and Spain.7 AbbVie's treatment is now licensed for use in all 28 member countries of the European Union, as well as in the U.S., Canada, Switzerland, Iceland, Liechtenstein and Norway.

https://www.bionity.com/en/news/151257/european-commission-grants-marketing-authorizations-for-abbvie-s-viekirax-exviera.html