Posted by Michael Wonder on 30 Apr 2018
European CHMP adopts positive opinion for Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide)
27 April 2018 - In clinical trials, Biktarvy demonstrated high efficacy and zero resistance through 48 weeks.
Gilead Sciences today announced that the CHMP), the scientific committee of the EMA, has adopted a positive opinion on the company’s marketing authorisation application for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.
The application for BIC/FTC/TAF is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective of non-inferiority at 48 weeks in all four studies.
