EMA accelerated assessment for Boehringer hep C candidate faldaprevir

Family-owned German drug major Boehringer Ingelheim says that its application for European marketing approval of faldaprevir, a potent second generation oral protease inhibitor, has been fully validated and granted accelerated assessment by the European Medicines Agency.

Boehringer Ingelheim is seeking marketing approval of faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV) for the treatment of a broad range of patients with genotype-1 (GT-1) hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease. If approved by the European Commission, faldaprevir could be available for marketing in the European Union in the second half of 2014.

Offers convenient dosing, as well as strong efficacy and safety profile, says company