AbbVie gets European Commission's approval to market VIEKIRAX + EXVIERA for HCV treatment

AbbVie (NYSE: ABBV) 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. 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.

"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, M.D., professor of medicine and chief of the department of medicine I, J.W. 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."

Treating hepatitis C is complex because the virus mutates and replicates rapidly. VIEKIRAX + EXVIERA are the first products to be approved as a combination treatment of three direct-acting antivirals with distinct mechanisms of action and non-overlapping resistance profiles to target hepatitis C at multiple steps in the viral lifecycle.

"With the approval of VIEKIRAX + EXVIERA in the European Union, we are offering a treatment that achieved high cure rates for people living with GT1 and GT4 chronic hepatitis C," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This is an important part of our ongoing commitment to advancing public health by applying innovative science to the development of promising medicines."

Robust Clinical Development Program
The approval of VIEKIRAX + EXVIERA is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The program consisted of six pivotal Phase 3 studies, which demonstrated that VIEKIRAX + EXVIERA cured 95-100 percent of hepatitis C patients with GT1 HCV infection who received the recommended regimen, with less than 2 percent of patients experiencing virologic failure.1,2 Additionally, more than 98 percent (n=2,011/2,053) of patients in clinical trials completed a full course of therapy. Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.

The approval of VIEKIRAX + EXVIERA is also based on the results from Phase 2 clinical trials in GT1 chronic HCV infected patients, which showed that VIEKIRAX + EXVIERA cured 97 percent (n=33/34) of liver transplant recipients, 92 percent (n=58/63) of patients co-infected with HIV-1 and 97 percent (n=37/38) of patients on opioid substitution therapy. Patients who achieve a sustained virologic response (SVR12) are considered cured of hepatitis C.

Approval of VIEKIRAX in GT4 chronic hepatitis C was based on a Phase 2 study in which patients treated with VIEKIRAX with RBV achieved 100 percent SVR12.




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