Gilead files elvitegravir and cobicistat with FDA; AHF plea on Quad pricing

29 June 2012

US biotech firm Gilead Sciences (Nasdaq: GILD), world’s largest maker of HIV drugs, has submitted a New Drug Application to the US Food and Drug Administration for approval of its elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.

Elvitegravir is also a component of Gilead’s once-daily Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) single tablet regimen, which is currently under US and European regulatory review for treatment-naive adult patients, the company noted. The drug is licensed from Japan Tobacco, which retains rights for the Japanese market.

The NDA for elvitegravir is supported by 96-week data from a pivotal Phase III study (Study 145) in which elvitegravir (150mg or 85mg) dosed once daily was non-inferior to the integrase inhibitor raltegravir (400 mg) dosed twice daily, each administered with a background regimen that included a fully active ritonavir-boosted protease inhibitor and a second antiretroviral.

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