Friday, November 21, 2014

AbbVie- European regulators recommended approval for hepatitis C drug Exviera (dasabuvir) and Viekirax (ombitasvir + paritaprevir + ritonavir)

Two new medicines recommended for the treatment of chronic hepatitis C

Additional treatment options with high cure rates to be available to patients

The European Medicines Agency (EMA) has recommended a marketing authorisation for Exviera (dasabuvir) and Viekirax (ombitasvir + paritaprevir + ritonavir) for the treatment of chronic hepatitis C virus (HCV) infection in adults in combination with other medicinal products for the treatment of chronic hepatitis C.

HCV infection is a major European public health challenge. It affects between 0.4% and 3.5% of the population in different European Union (EU) Member States and is the most common single cause of liver transplantation in the EU.

Exviera and Viekirax belong to a new generation of medicines for chronic HCV infection that have high cure rates and have recently reshaped the way this disease is treated. Both Exviera and Viekirax block the action of proteins which are essential for HCV replication. Exviera targets the protein NS5B while Viekirax targets the proteins NS5A and NS3/4A.

This new generation of medicines allows cure of patients with chronic HCV infection without the need for interferons. Until recently, interferons were part of all treatment regimens for chronic HCV infection; these medicines can cause severe side effects that rule out their use in a considerable proportion of HCV patients.

Over the last year, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisations for four new medicines for the treatment of HCV. In this area, the more treatment options that are available, the better chance a patient has to get the right treatment to cure the disease and to lead a longer and healthier life.

Both Exviera and Viekirax were evaluated under EMA’s accelerated assessment mechanism, a tool which aims to speed up patients’ access to new medicines where there is an unmet medical need.

For both medicines, the applicant received scientific advice from EMA in relation to quality, non-clinical and clinical aspects.

The opinion adopted by the CHMP at its November 2014 meeting is an intermediary step on Exviera and Viekirax’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State taking into account the potential role/use of this medicine in the context of the national health system of that country.

The applicant for both Exviera and Viekirax is AbbVie.
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Two new medicines recommended for the treatment of chronic hepatitis C (English only)21/11/2014 

CHMP Grants Positive Opinions of AbbVie's VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe

- Major regulatory milestone achieved toward approval in the European Union
- Final decision from the European Commission expected in the first quarter of 2015

November 21, 2014: 08:00 AM ET

NORTH CHICAGO, Ill., Nov. 21, 2014 /PRNewswire/ -- The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions for AbbVie's (NYSE: ABBV) investigational, all-oral, interferon-free treatment of VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) with or without ribavirin (RBV) for patients with genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus (HCV) infection. 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.

Robust Clinical Program Supported Positive Opinions
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.10 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.

About AbbVie's Investigational Chronic HCV Treatment
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.

Additional information about AbbVie's HCV development program can be found on

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