EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATIONS FOR ABBVIE

Jan 16, 2015

NORTH CHICAGO, Ill., Jan. 16, 2015/PRNewswire/ - AbbVie (NYSE: ABBV) declared that the European Commission has conceded showcasing approvals for its all-oral, short-course, sans interferon treatment of VIEKIRAX®(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets).1,2 The treatment has been sanction with or without ribavirin (RBV) for patients with genotype 1 (GT1) endless hepatitis C infection (HCV) contamination, incorporating those with remunerated liver cirrhosis, HIV-1 co-disease, patients on opioid substitution treatment and liver transplant recipients.1,2Additionally, VIEKIRAX has been endorsed for use with RBV in genotype 4 (GT4) ceaseless hepatitis C patients.1

"The endorsement of AbbVie's hepatitis C treatment in the European Union, after the late supports in the U.S. what's more, Canada, offers patients crosswise over Europe another and viable treatment to cure this genuine sickness," said Richard Gonzalez, director of the board and CEO, AbbVie. "We are focused on working with neighborhood governments and medicinal services frameworks to bolster wide access to VIEKIRAX + EXVIERA."

The approbations take after a survey under quickened evaluation by the European Medicines Agency, assigned to new prescriptions of significant general wellbeing hobby. Roughly nine million individuals in Europe are tainted with perpetual hepatitis C, a noteworthy reason for liver malignancy and liver transplantation.4 Genotype 1 is the most pervasive type of hepatitis C in Europe, representing 60 percent of cases worldwide.5 In Europe, the most predominant sub-genotype is 1b (47 percent).6 Genotype 4, most normal in the Middle East, sub-Saharan Africa and Egypt, is turning out to be progressively common in a few European nations, including Italy, France, Greece and Spain.7 AbbVie's treatment is presently authorized for use in each of the 28 part nations of the European Union, and also in the U.S., Canada, Switzerland, Iceland, Liechtenstein and Norway.

"Hepatitis C is an unpredictable ailment, with various genotypes and uncommon patient populaces that should be considered when deciding the right treatment for an individual patient," said Stefan Zeuzem, M.D., teacher of pharmaceutical and head of the division of drug I, J.W. Goethe University Hospital, Frankfurt, Germany. "In clinical trials, AbbVie's treatment accomplished high cure rates with low rates of stopping over a mixture of patient populaces, making it an essential expansion to the class of treatments that is changing the way hepatitis C is being dealt with."

Treating hepatitis C is intricate in light of the fact that the infection transforms and duplicates quickly. VIEKIRAX + EXVIERA are the first items to be affirmed as a blend treatment of three direct-acting antivirals with particular components of activity and non-covering resistance profiles to target hepatitis C at different strides in the viral lifecycle.1,2

"With the approbation of VIEKIRAX + EXVIERA in the European Union, we are putting forth a treatment that accomplished high cure rates for individuals living with GT1 and GT4 ceaseless hepatitis C," said Michael Severino, M.D., official VP, innovative work and boss investigative officer, AbbVie. "This is a vital piece of our continuous responsibility to applying so as to propel general wellbeing creative science to the improvement of promising drugs.