CHMP grants positive opinions of AbbVie’s VIEKIRAX + EXVIERA to treat chronic hepatitis C

The European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.

"The CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

"Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse."

The marketing authorization applications (MAAs) 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 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)1,2,3,4,5 including 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 cirrhosis6, as well as preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients7 and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection who were new to treatment after transplantation.8

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.9,10 Genotype 1 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).11 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.12

The U.S. Food and Drug Administration (FDA) granted priority review for AbbVie’s treatment for patients with GT1 chronic HCV infection on June 13, 2014.

AbbVie’s treatment 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.

VIEKIRAX + EXVIERA is being investigated for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily, with or without ribavirin, dosed twice daily.

AbbVie’s chronic HCV treatment combines three direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

For genotype 4 chronic HCV patients, AbbVie’s treatment consists of the fixed-dose combination of paritaprevir/ritonavir (150mg/100mg) with ombitasvir (25mg) only, dosed once daily with ribavirin, dosed twice daily.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of hepatitis C.