Complete Response Letters Issued for Elvitegravir and Cobicistat

Gilead Sciences announced that it has received Complete Response Letters from the FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens. Elvitegravir, an integrase inhibitor, blocks the ability of HIV to integrate into the genetic material of human cells. Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Unlike ritonavir, cobicistat acts only as a pharmacoenhancing or “boosting” agent and has no antiviral activity.

Elvitegravir and cobicistat are also components of Gilead’s once-daily single tablet HIV-1 regimen Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), which was approved by FDA in August 2012 for treatment-naïve adults. This regulatory action does not affect the marketing authorization or continued use of Stribild.

Gilead previously submitted its NDAs for elvitegravir and cobicistat in June 2012.

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