- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Gilead Sciences' (GILD) Genvoya (elvitegravir 150 mg/cobicistat 150mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg) for the treatment of HIV-1 infection. The data in the marketing application supports the use of Genvoya in treatment-naive adults and adolescents, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment.
- TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at one tenth the dose of Viread (tenofovir disoproxil fumarate) while exerting less stress on the bones and kidneys.
- A final decision by the European Commission usually takes ~60 days.