Gilead Sciences’ new HIV therapy accepted for EU regulatory review

Gilead Sciences has had its marketing authorisation application for a new HIV therapy accepted for review by the European Medicines Agency.

The investigational once-daily single-tablet regimen contains bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide. It is designed for the treatment of HIV-1 infections in adults.

This combination has demonstrated high rates of virologic suppression and no treatment-emergent resistance over 48 weeks in phase III clinical trials, when used among treatment-naive adult patients and virologically-suppressed adult patients who switched regimens.

Three completed phase III studies have demonstrated the effectiveness of the drug, with a fourth still ongoing.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "Gilead remains at the forefront of driving innovation in HIV, with our continued commitment to working to simplify and improve treatments for people living with HIV."

This comes after the firm applied for US regulatory approval of the new combination regimen last month.

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