European regulators have approved AbbVie’s all-oral, interferon-free hepatitis C drug.
The company announced today that the European Commission (EC) has granted marketing authorizations for Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) for treatment with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection (HCV), patients on opioid substitution therapy and liver transplant recipients. The treatment has been approved with or without ribavirin.
Additionally, Viekirax has been approved for use with ribavirin (RBV) in patients with genotype 4 (GT$) chronic hepatitis C.
The treatment was approved under the accelerated process. The approval comes a month after the company received approval from the US Food and Drug Administration (FDA). The cocktail is branded as Viekira Pak in the US.
“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,” 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.”
There are approximately nine million people infected with chronic hepatitis C in Europe. Genotype 1 is the most common form of the disease in Europe, accounting for 60 percent of cases worldwide.
“Hepatitis C is a complex disease, with multiple genotypes and special patient populations that need to be considered when determining the right treatment for an individual patient,” said Stefan Zeuzem, MD, professor of medicine and chief of the department of medicine I, JW Goethe University Hospital, Frankfurt, Germany. “In clinical trials, AbbVie’s treatment achieved high cure rates with low rates of discontinuation across a variety of patient populations, making it an important addition to the class of therapies that is changing the way hepatitis C is being treated.”
Source: AbbVie, Inc.