Stribild regulatory update

FDA approved an sNDA from Gilead for Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate to treat HIV-1 infection in pediatric patients ages ≥12 weighing ≥35 kg. The drug is approved in adults who have no history of antiretroviral therapy (ART) or as replacement therapy for virologically suppressed patients on a stable ART regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to Stribild’s components. Stribild is a once-daily tablet comprising Vitekta elvitegravir and Gilead’s Tybost cobicistat and Truvada emtricitabine/tenofovir...