Gilead’s Quad HIV therapy accepted for US FDA review

Gilead Sciences has achieved another milestone in its development of the Quad treatment regimen for HIV after it was accepted for regulatory review in the US.

The Food and Drug Administration (FDA) has ratified the company's new drug application for the innovative combination therapy this month and has established a target review date of August 27th 2012.

Quad combines four Gilead compounds – elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate – into a single-tablet regimen that offers potentially significant clinical and convenience benefits.

The FDA's decision comes in the same month that Gilead also submitted the new product for review by the European Medicines Agency, with the aim of seeking approval for the drug across all 27 EU nations.

Gilead's submissions are based on strong data from phase III clinical trials, which have demonstrated Quad's safety and efficacy.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said the company is seeking to "bring this new single-tablet regimen to physicians and patients as quickly as possible".