Enanta Announces that AbbVie Receives CHMP Positive Opinion for MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
- If approved, MAVIRET™ will provide a shorter, 8-week, pan-genotypic (GT1-6), once-daily treatment option for the majority of people living with chronic hepatitis C virus (HCV)
- MAVIRET would also be an additional HCV treatment option for patients with specific treatment challenges, such as those with compensated cirrhosis, chronic kidney disease and genotype 3
Final European Commissiondecision expected Q3 2017
- Glecaprevir is Enanta’s second protease inhibitor being developed
through its collaboration with
AbbVieand is one of the two new direct-acting antivirals (DAAs) in MAVIRET
The CHMP positive opinion is supported by 97.5 percent (n=807/828) SVR12 rates with 8 weeks of MAVIRET across GT1-6 chronic HCV-infected patients without cirrhosis and new to treatment, with varied patient and viral characteristics.2 In an integrated analysis (n=2,265), less than 0.4 percent of patients discontinued treatment.3 The reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.3 The type and severity of adverse reactions in patients with cirrhosis were comparable overall to those seen in patients without cirrhosis.3
“HCV is a global health problem and MAVIRET has the potential to address
the majority of patients with a simple 8-week treatment option,” stated
MAVIRET is also intended to be an additional option for patients with specific treatment challenges. These include chronic HCV patients with compensated cirrhosis (Child-Pugh A), and those who currently have limited treatment options, such as patients with severe chronic kidney disease, including those on dialysis, and patients infected with genotype 3.
The marketing authorization application (MAA) for MAVIRET is under an
accelerated assessment, which is granted by the EMA to new medicines of
major public health interest. The MAA evaluation is conducted under the
European Union’s centralized licensing procedure, and if approved will
result in a marketing authorization valid in all 28 member states of the
About MAVIRET™ (glecaprevir/pibrentasvir)
AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) clinical development program was designed to investigate a pan-genotypic, once-daily, ribavirin-free treatment with the potential to provide a faster path to virologic cure** for all major HCV genotypes (GT1-6) and with the goal of addressing specific treatment challenges, including compensated cirrhosis (Child-Pugh A), chronic kidney disease and genotype 3. MAVIRET is being evaluated as a potential 8-week, pan-genotypic treatment for the majority of people living with HCV,1 namely those without cirrhosis and new to treatment,* and regardless of viral and patient characteristics.
MAVIRET is a fixed-dose combination of two distinct antiviral agents: glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.
*Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including
statements with respect to the prospects for commercialization
regulatory approval for MAVIRET. Statements that are not historical
facts are based on management’s current expectations, estimates,
forecasts and projections about Enanta’s business and the industry in
which it operates and management’s beliefs and assumptions. The
statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of
2Puoti et al. High SVR rates with 8 and 12 weeks of
pan-genotypic G/P: integrated efficacy analysis of genotype 1–6 patients
without cirrhosis. Presented at: 52nd Annual Meeting of the
3Dufour et al Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1–6 FRI-238 Hepatitis C Virus Infection: An Integrated Analysis