FDA Accepts Two NDAs for HIV Therapy
Gilead announced that the FDA has accepted its New Drug Applications (NDAs) for cobicistat, a boosting agent that increases blood levels of the protease inhibitors atazanavir and darunavir, and elvitegravir, an integrase inhibitor, for the treatment of HIV-1 infection in treatment-experienced adults.
The NDAs for cobicistat and elvitegravir were submitted in June 2012. In April 2013, the company received Complete Response Letters from the FDA. In its communications, the FDA stated that it could not approve the cobicistat and elvitegravir applications in their current forms, citing deficiencies in documentation and validation of certain quality testing procedures and methods that were observed during inspections. Gilead has worked with the FDA to address the questions raised in the Complete Response Letters.
Cobicistat and elvitegravir are components of Gilead's already approved drug, Stribild (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg), a once-daily single tablet regimen for the treatment of HIV-1 infection.
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