Gilead Sciences receives US approval for Stribild HIV therapy

Gilead Sciences has achieved a key developmental milestone for its new HIV treatment Stribild after attaining US regulatory approval for the combination therapy.

The US Food and Drug Administration has ratified the product, which was known as Quad during its development, based on positive 48-week safety and efficacy data from two pivotal phase III clinical trials.

Stribild combines four compounds – the integrase inhibitor elvitegravir and the pharmacoenhancing agent cobicistat, plus emtricitabine and tenofovir disoproxil fumarate – into a single daily tablet.

Applications for marketing approval of the drug are also pending in Europe, Australia and Canada.

Dr John Martin, chairman and chief executive officer at Gilead Sciences, said: "Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success."

Last month, the company allied with a number of pharmaceutical industry partners based in India to expand access to emtricitabine among HIV patients in poorer nations.