Saturday, June 24, 2017
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted AbbVie a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week treatment option for HCV patients across all genotypes (GT1-6) without cirrhosis and new to treatment, who comprise the majority of people living with HCV. The European Commission will now review the CHMP opinion and a final decision is expected in the next quarter. Glecaprevir is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals (DAAs) combined 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. In an integrated analysis (n=2,265), less than 0.4 percent of patients discontinued treatment. The reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue. The type and severity of adverse reactions in patients with cirrhosis were comparable overall to those seen in patients without cirrhosis.
“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 Jay R. Luly, Ph.D., President and CEO, Enanta. “We are pleased to have our second protease inhibitor be part of this exciting new HCV regimen.”
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 European Union, as well as Iceland, Liechtenstein and Norway. It would then be subject to separate reimbursement approvals in each of the member states. AbbVie’s investigational, pan-genotypic combination of glecaprevir/pibrentasvir has also been granted priority review designations by the U.S. Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare. MAVIRET is an investigational regimen and its safety and efficacy have not been established by any regulatory approval.