— 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 OpinionsThe
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
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 TreatmentVIEKIRAX™
+ 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
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 www.clinicaltrials.gov.