AbbVie receives recommendation for new EU approval of hepatitis C drug

AbbVie has announced that its new hepatitis C drug Viekirax has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the use of a 12-week Viekirax regimen with ribavirin in genotype 4 chronic hepatitis C virus-infected adult patients with compensated cirrhosis.

Currently, the therapy is approved for use in Europe in this indication over the course of 24 weeks, but this shortened treatment programme may soon also be ratified having demonstrated its safety and efficacy in clinical studies.

Data from the phase III trial AGATE-I showed that the 12-week programme delivered a sustained virologic response in patients.

Dr Michael Severino, executive vice-president for research and development and chief scientific officer at AbbVie, said: "This milestone is progress toward an approval that would allow us to provide the opportunity for a cure with just 12 weeks of our regimen to genotype 4 patients with or without compensated cirrhosis in Europe."

This comes after AbbVie and Biogen's once-monthly multiple sclerosis therapy Zinbryta was approved in Europe earlier this month.