Gilead receives EU approval for hepatitis C drug Harvoni

Gilead Sciences has announced that the European Commission has approved its innovative new hepatitis C therapy Harvoni.

The drug is the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infections in adults, and eliminates the need for the use of interferon and ribavirin.

It combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir and is recommended in treatment-naive and treatment-experienced cirrhotic and non-cirrhotic patients, with a treatment duration of 12 or 24 weeks, depending on prior treatment history and cirrhosis status.

The authorisation is based on a clinical development programme that included more than 2,000 patients and follows an accelerated assessment by the European Medicines Agency.

Dr Graham Foster, professor of hepatology at Queen Mary University of London, said: "With Harvoni, we have the potential to transform the way we treat people living with the most prevalent form of hepatitis C in Europe."

Earlier this month, the company reported positive clinical trial data showing the benefits that Harvoni can offer to patients with hard-to-treat cases of hepatitis C.