EU CHMP recommends approval of Maviret (glecaprevir/pibrentasvir) for adults with chronic hepatitis C virus- AbbVie

AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of Maviret (glecaprevir/pibrentasvir) for adults with chronic hepatitis C virus (HCV) infection. If approved, Maviret will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6), 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 Q3 2017.

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 who are 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 overall comparable to those seen in patients without cirrhosis.

Maviret is also intended to be an additional option for patients with specific treatment challenges. This includes 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.

Comment: The marketing authorization application (MAA) for Maviret is under an accelerated assessment by the EMA, which is granted to new medicines of major public health interest.