Regulatory Affairs

AbbVie’s Maviret approved in Europe for chronic hepatitis C

PBR Staff Writer Published 31 July 2017

AbbVie’s maviret (glecaprevir/pibrentasvir) has secured the approval of the European Commission for the treatment of chronic hepatitis C virus (HCV) infection in all major genotypes from GT1 to GT6 in adult patients.

Maviret is intended to be taken daily once for eight weeks. It is free from ribavirin and is a pan-genotypic treatment for patients not suffering from cirrhosis and who were not previously treated.

Maviret is a combination of 100mg of the NS3/4A protease inhibitor glecaprevir and 40mg of the NS5A inhibitor pibrentasvir. The drug was shown to have cured 97.5% in 8 weeks of treatment in GT1-6 patients free from cirrhosis and whose disease was not treated before.

AbbVie research and development executive vice president and chief scientific officer Michael Severino said: "MAVIRET represents an innovation in HCV care as an 8-week, pan-genotypic option that combines two distinct antiviral agents and has high efficacy even against most genotypes commonly associated with resistance to treatment.

“This new treatment advancement has the potential to meet the diverse needs of patients in as short as 8 weeks across Europe.”

AbbVie stated that it had bagged the marketing authorization in Europe for the hepatitis drug after filing positive data from eight registrational studies carried out in more than 2,300 patients globally, covering all important HCV genotypes and special populations.

Maviret has also been approved to treat patients facing specific treatment challenges like those with compensated cirrhosis for all major genotypes. It has also been covered to treat patients who had limited treatment options in the past like those with severe chronic kidney disease (CKD) or the ones with genotype 3 (GT3) chronic HCV infection.

The drug is now licensed to be used in all the European Union member states along with Norway, Liechtenstein and Iceland.

Outside of Europe, maviret has been put under accelerated review by the US Food and Drug Administration (FDA) and also by the Japanese Ministry of Health, Labour and Welfare.

Image: AbbVie’s corporate headquarters in Lake Bluff, Illinois, US. Photo: courtesy of AbbVie Inc.