AbbVie said a subcommittee of the European Medicines Agency has recommended marketing authorization approval of hepatitis C drug Maviret, a step toward broadening the available treatments for patients with liver and kidney disease in approximately 30 European and Scandinavian countries.
The recommendation will now be reviewed by regulators and a decision by the European Commission is expected by the third quarter of this year, AbbVie said in a release.
Maviret, offered in a three-tablet dose, treats several types of hepatitis C and is effective for those on dialysis or have cirrhosis (scarring of the liver), the release said.
“Maviret represents a new generation of HCV (hepatitis C virus) therapy and has the potential to be a shorter, eight-week option for patients living with this serious, chronic illness," Michael Severino, AbbVie’s executive vice president of research and development and chief scientific officer, said in the release.
Early tests have shown Maviret works for different strains of the hepatitis C virus, and it is being evaluated for long-term efficacy and safety, the release stated.
Maviret has been granted accelerated review by the U.S. Food and Drug Administration, the release said.