AbbVie receives CHMP positive opinion for Maviret for chronic HCV

AbbVie has received a positive opinion from the Committee for Medicinal Products for Human Use for its ribavirin-free regimen Maviret for the treatment of chronic hepatitis C of all genotypes, according to a press release.

“Maviret is the culmination of AbbVie’s efforts to provide one pan-genotypic regimen for as many patients living with HCV as possible,” Janet Hammond, vice president and therapeutic area head of virology, told Healio.com. “CHMP is an important milestone in our ongoing journey to bring our treatment to patients in Europe, and if approved, will provide an 8 week option for the majority of patients, as well as an additional option for specific patients who currently have limited options, like those with severe chronic kidney disease.”

Maviret (glecaprevir/pibrentasvir) is a once-daily, 8-week regimen for patients with HCV of any genotype without cirrhosis who are treatment-naive. Data supporting the positive opinion includes a rate of 97.5% sustained virologic response at 12 weeks among 828 patients treated for 8 weeks with Maviret and a rate of less than 0.4% drop-out in a cohort of 2,265 patients.

The marketing authorization application is under accelerated assessment by the European Medicines Agency for approval in the 28 European Union countries, Norway, Liechtenstein and Iceland. The European Commission’s decision on the CHMP opinion is expected in the third quarter of 2017.

Additionally, Maviret has been granted accelerated review by the FDA and by the Japanese Ministry of Health, Labor and Welfare.

References: www.abbvie.com