CHMP recommends approval of marketing extension for Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) in adolescents with HIV.- Gilead Sciences.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), from Gilead Sciences.
It recommends the addition of: Stribild is also indicated for the treatment of HIV-1 infection in adolescents aged 12 up to 18 years weighing at least 35 kg who are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil fumarate (TDF).
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