AbbVie Hep C combo pill ready for Europe
pharmafile | January 16, 2015 | News story | Medical Communications | AbbVie, Exviera, FDA, HIV, Viekira Pak, Viekirax, harvoni, hep C, sovaldi
The European Commission has approved AbbVie’s Viekirax and Exviera for the treatment of chronic hepatitis C (HCV).
Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir) is the first product to be given the green light as a combination therapy for patients with genotype 1 (GT1) HCV, including those with compensated liver cirrhosis and HIV.
“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,” comments Richard Gonzalez, chairman and chief executive of AbbVie.
The authorisation of the combined medication is based on the results from Phase II clinical trials showing that the regimen cured 97% of liver transplant recipients. It is also supported by 2,300 strong Phase III studies which demonstrated that the pill cured 95-100% of HCV sufferers with GT1 HCV, with only 2% of patients experiencing virologic HIV failure.
“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,” says Professor Stefan Zeuzem, who is the chief of the department of medicine at the Goethe University Hospital in 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,” adds Zeuzem.
The US biopharma firm gained US sign-off in December for its version of the treatment Viekira Pak (dasabuvir) to challenge Gilead’s dominance of the growing market for new HCV medicines.
According to the World Health Organization (WHO) around 130–150 million people globally have chronic HCV, and a significant number of those will develop liver cirrhosis or liver cancer. More common in men, 350,000 to 500,000 people die each year from liver diseases related to the infection.
An infectious illness affecting primarily the liver, HCV is a virus that can be transmitted sexually or passed on from an infected mother to her baby. It can also be passed on via the transfusion of unscreened blood products.
Tom Robinson
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