Gilead Sciences receives CHMP backing for hepatitis C drug

Gilead Sciences has been granted a recommendation for European regulatory approval of Harvoni, its new once-daily tablet therapy for chronic hepatitis C virus (HCV) infection in adults.

The Committee for Medicinal Products for Human Use (CHMP) has endorsed the prospective launch of the investigational therapy, which combines the NS5A inhibitor ledipasvir and the nucleotide analog polymerase inhibitor sofosbuvir.

Data from three phase III studies have demonstrated the safety and efficacy of Harvoni among nearly 2,000 genotype 1 HCV patients with compensated liver disease. This included cirrhotic and non-cirrhotic patients who were new to HCV treatment and those who had failed prior therapy with an interferon-based regimen.

The CHMP opinion was adopted following an accelerated review procedure, which is allocated to medicinal products that are expected to be of major public health interest.

Following this, the European Commission will consider whether or not to provide the new drug with a finalised approval.

This comes after the firm's oral cancer therapy Zydelig was approved in Europe for the treatment of two incurable forms of blood cancer earlier this month.