CHMP gives positive opinions of AbbVie’s VIEKIRAX™ and EXVIERA™

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs primarily in the infectious disease field, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions for AbbVie’s investigational, all-oral, interferon-free treatment of VIEKIRAX™ (a combination of ombitasvir, paritaprevir (ABT-450) and ritonavir) plus EXVIERA™ (dasabuvir), with or without ribavirin (RBV), for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, and VIEKIRAX™ only, with RBV, for patients with genotype 4 (GT4) HCV infection. AbbVie anticipates that the European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.

Paritaprevir is the generic name for ABT-450, an NS3/4A protease inhibitor that is Enanta’s lead HCV candidate discovered during the ongoing collaboration between AbbVie and Enanta for HCV protease inhibitors and regimens that include protease inhibitors.

VIEKIRAX™ + EXVIERA™ is being investigated for the treatment of genotype 1 chronic HCV infection

The combination of three direct-acting antivirals (3-DAA) consisting of VIEKIRAX™ + EXVIERA™ is being investigated for the treatment of genotype 1 chronic HCV infection, including patients with compensated cirrhosis. VIEKIRAX™ consists of the fixed-dose combination of paritaprevir 150mg and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor), dosed twice daily with or without ribavirin.

For genotype 4 chronic HCV patients, AbbVie’s treatment is a combination of two direct-acting antivirals (2-DAA) consisting of VIEKIRAX™, dosed once daily, plus ribavirin, dosed twice daily.

“These positive opinions are an important step in bringing to market a potential new cure for patients living with hepatitis C virus,” stated Jay R. Luly, Ph.D, President and CEO. “We are thrilled that our protease inhibitor paritaprevir is part of such an important regimen and look forward to the European Commission’s final decision anticipated in the first quarter of 2015.”

The marketing authorization applications (MAAs) for these regimens were submitted to the EMA on May 6, 2014 under an accelerated assessment, designated to new medicines of major public health interest. Review of the MAAs is being conducted under the centralized licensing procedure, which if approved will result in marketing authorizations valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

The positive CHMP opinions are supported by a robust clinical development program consisting of six pivotal Phase 3 studies – SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV, and TURQUOISE-II. AbbVie’s treatment regimen was evaluated in more than 2,300 GT1 patients in over 25 countries. In addition, the positive opinions were supported by a Phase 2 study, PEARL-I, in GT4 patients without cirrhosis , as well as preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection patients new to treatment after transplantation.

AbbVie estimates that approximately nine million people in Europe are infected with HCV, which over time may lead to cirrhosis and liver failure in about 10-20 percent of people with chronic HCV. GT1 is the most common type of HCV genotype9, accounting for 60 percent of cases worldwide. In Europe, the most prevalent genotype is 1b (47 percent). GT4, 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.

The U.S. Food and Drug Administration (FDA) granted priority review for AbbVie’s investigational 3-DAA treatment regimen for patients with GT1 chronic HCV infection on June 13, 2014. The regimen was also granted Breakthrough Therapy designation by the FDA, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.