Gilead Sciences’ new hepatitis C drug validated for EU review

Gilead Sciences has announced that the European Medicines Agency has accepted its new chronic hepatitis C virus (HCV) therapy sofosbuvir for review.

The regulatory body has validated the marketing authorisation application for the once-daily oral nucleotide analogue inhibitor, which is intended for use with ribavirin in the treatment of a number HCV genotypes.

Data from the phase III studies Neutrino, Fission, Positron and Fusion has demonstrated that Gilead's drug can offer superior or non-inferior performance to currently available treatment options or historical controls.

If approved, sofosbuvir could be available for marketing in the EU in the first half of 2014, while a US regulatory application has also been submitted.

Dr John Martin, chairman and chief executive officer of Gilead Sciences, said: "Sofosbuvir has the potential to improve cure rates, while reducing the duration of HCV therapy and reducing or eliminating the need for interferon injections."

The compound was originally discovered by Pharmasset and its promising performance in clinical studies informed Gilead's decision to acquire the company last year.