Gilead’s Epclusa recommended for new EU hepatitis C approval

Gilead Sciences has announced that its hepatitis C therapy Epclusa has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on the company's marketing authorisation application for the investigational, pan-genotypic once-daily combination therapy.

Combining the effects of sofosbuvir and velpatasvir, the therapy is intended for the treatment of chronic hepatitis C viral infections spanning all six major genotypes. It has demonstrated its safety and efficacy across four phase III studies.

The CHMP's positive opinion was based on the positive findings of these trials and was adopted following an accelerated review procedure, which is reserved for medicinal products expected to be of major public health interest.

A final decision from the European Commission is now expected in the coming months.

The active ingredient sofosbuvir is currently approved in Europe under the brand name Sovaldi, while a fixed-dose combination of sofosbuvir and ledipasvir called Harvoni is also available from Gilead.