Gilead Sciences’ cobicistat accepted for EMA review

Gilead Sciences has announced that its pharmacoenhancing or "boosting" agent cobicistat has been accepted for regulatory review by the European Medicines Agency (EMA).

The company filed a marketing authorisation application for the product that has now been validated by the EMA, meaning a review can now take place under the EU's centralised licensing procedure.

Cobicistat is designed to increase blood levels of certain commercially available protease inhibitors – including atazanavir and darunavir – in order to enable once-daily dosing.

Currently, ritonavir is the only agent used to boost HIV therapy, but clinical studies carried out by Gilead have shown that cobicistat can offer comparable efficacy.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "With today's EMA validation, we're hopeful that we may soon be able to offer an important new boosting option for patients who rely on protease inhibitors as part of their HIV therapy."

Earlier this month, the company commenced a phase III clinical trial of GS-1101, a promising new treatment for chronic lymphocytic leukaemia.