CHMP recommends approval of Biktarvy for HIV-1 infection.- Gilead Sciences.
Gilead Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the company’s Marketing Authorization Application for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) 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 MAA for BIC/FTC/TAF is supported by data from four ongoing Phase III 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.
BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018.
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