Positive EMA/CHMP opinion for Gilead’s Genvoya

26 September 2015

US biotech giant Gilead Sciences (Nasdaq: GILD) has received a positive opinion form the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency for its investigational, once-daily single tablet regimen Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide (TAF) 10mg) for the treatment of HIV-1 infection.

The data submitted in the marketing application support the use of the regimen among adult and adolescent treatment-naïve individuals, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment, the company noted.

The benefits with Genvoya are its ability to achieve a potent antiretroviral response in a once daily, single pill regimen. The most common side effect is nausea. Genvoya was associated with low impact on renal safety and bone mineral density compared to the licensed tenofovir disoproxil, according to the EMA.

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