Gilead Sciences receives EU green light for hepatitis C drug assessment

Gilead Sciences has announced that the European Medicines Agency (EMA) has ratified its application for the assessment of a new treatment of chronic hepatitis C virus (HCV) infections.

The regulator has accepted the company's marketing authorisation application for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic HCV genotype 1.

A full assessment of the therapy will now take place, examining positive data from clinical trials showing the safety and efficacy of the new combination.

The EMA has also accepted Gilead's request for accelerated assessment of LDV/SOF, a designation that is granted to new medicines of major public health interest.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer at Gilead, said: "LDV/SOF has the potential to transform HCV therapy for genotype 1 patients by eliminating the need for interferon injections and ribavirin and reducing the duration of treatment."

The company also filed for US Food and Drug Administration approval of the therapy in February 2014.