Gilead Sciences receives CHMP backing for new hepatitis C therapy

Gilead Sciences has announced that its new hepatitis C therapy Sovaldi has been granted a recommendation by Europe's Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has issued a positive opinion endorsing the approval of the drug for the treatment of chronic hepatitis C virus infections in adults.

Sovaldi is an investigational once-daily oral nucleotide analogue polymerase inhibitor and has been recommended for use in combination with other agents, with data from six clinical trials demonstrating the safety and efficacy benefits of the drug.

To date, nearly 3,000 patients have received at least one dose of Sovaldi in phase II or III studies, revealing its strong tolerability profile and numerous potential benefits.

The CHMP opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest. A final decision from the European Commission is expected in the next few months.

This comes after the company was granted EU approval for Vitekta, a tablet-based integrase inhibitor therapy for HIV, earlier this month.