EMA validates Gilead Sciences’ marketing application for BIC/FTC/TAF combination
US biopharmaceutical company Gilead Sciences’ marketing authorisation application (MAA) for a fixed-dose drug combination to treat HIV-1 infection in adults has been fully validated and is currently under evaluation by the European Medicines Agency (EMA).
The fixed-dose combination is an investigational, once-daily single tablet regimen that comprises 50mg of bictegravir (BIC), a new investigational integrase strand transfer inhibitor (INSTI); and 200mg/25mg of emtricitabine (FTC) / tenofovir alafenamide (TAF).
During the Phase III clinical trials, BIC/FTC/TAF has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks among treatment-naïve adult patients, as well as virologically suppressed adult patients who switched regimens.
Gilead Sciences chief scientific officer and research and development executive vice-president Dr Norbert Bischofberger said: “This investigational single tablet regimen represents a potential advancement in HIV treatment by combining the potency of an integrase inhibitor, bictegravir, with the demonstrated safety profile of the FTC/TAF backbone.
“Gilead remains at the forefront of driving innovation in HIV, with our continued commitment to working to simplify and improve treatments for people living with HIV.”
Gilead Sciences’ MAA is supported by data from four Phase III trials, in which the regimen met its primary objective of non-inferiority at 48 weeks.
Three of the four ongoing studies are being carried out to evaluate the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing 50mg of dolutegravir (DTG); two in treatment-naïve patients and one in virologically suppressed patients switching from an existing DTG-containing antiretroviral regimen.
The fourth study conducted on virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside / nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.
The MAA filing for BIC/FTC/TAF will be reviewed by the EMA under the centralised licensing procedure for all 28 member states of the European Union, as well as Norway and Iceland.