CHMP recommends change to approval of Genvoya for 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 Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg), from Gilead Sciences, in treating HIV.
The CHMP adopted an extension to the existing indication as follows: Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir, as follows: In adults and adolescents aged from 12 years and with body weight at least 35 kg, and in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to resistance or toxicities.
Comment: Genvoya was approved by the European Commission on 19 November 2015 and by the FDA on 5 November 2015.
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