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|European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV|
– EMA MAA Validation Follows Submission of NDA for BIC/FTC/TAF to
BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.
“This investigational single tablet regimen represents a potential
advance in HIV treatment by combining the potency of an integrase
inhibitor, bictegravir, with the demonstrated safety profile of the
FTC/TAF backbone,” said
The MAA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority at 48 weeks. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir (50mg; DTG); two in treatment-naïve patients and one in virologically suppressed patients (HIV-1 RNA levels <50 copies/mL) switching from an existing DTG-containing antiretroviral regimen. A fourth ongoing study in 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 BIC/FTC/TAF filing will be reviewed by the EMA under the centralized
licensing procedure for all 28 member states of the
Gilead submitted a New Drug Application (NDA) for BIC/FTC/TAF in
Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.
About Gilead Sciences
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including EMA and
other regulatory agencies may not approve BIC/FTC/TAF, and any marketing
approvals, if granted, may have significant limitations on its use.
These risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended
For more information on
Gilead Sciences, Inc.