Gilead Sciences applies for European approval of Quad

Gilead Sciences has had its submission for European approval of its innovative new combination HIV therapy Quad validated for review.

The European Medicines Agency will be considering the company's application for the new therapy to be licensed for use among adult patients affected by HIV-1 infection, based on positive results from phase III trials.

Quad is a new single-tablet regimen that combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, providing numerous clinical advantages while offering greater convenience for patients.

This follows the submission of a US regulatory application in October 2011 and could see the drug receive approval for sale in all 27 EU nations.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "We look forward to working with European regulatory authorities to bring this new single-tablet regimen to physicians and patients as quickly as possible."

This comes after the company announced positive data from a phase III study of elvitegravir, one of the components of Quad, earlier this month.