AbbVie’s new hepatitis drug validated for EU review

AbbVie has announced that its innovative all-oral therapy for chronic genotype 1 hepatitis C has been accepted for European regulatory review.

Marketing authorisation applications for the investigational interferon-free regimen for the treatment of adult hepatitis C patients have been validated and are under accelerated assessment by the European Medicines Agency.

The submissions were supported by data from a large clinical programme including six phase III studies involving more than 2,300 patients in over 25 countries.

Accelerated assessment processes are available for new medicines that are deemed to be of major public health interest. If approved, AbbVie's regimen could be available for sale in the EU in the first quarter of 2015.

The drug was also accepted for priority review by the US Food and Drug Administration earlier this month.

AbbVie considers the new hepatitis C therapy to be a strategically important product and recently opened a newly-expanded manufacturing facility in Sligo in order to support the future development of the drug.