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Gilead gets FDA priority review for bictegravir regimen for HIV treatment

Published 11 August 2017

The US Food and Drug Administration (FDA) has granted priority review for Gilead Sciences’ New Drug Application (NDA) for its investigational, fixed-dose combination of bictegravir (50mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection.

Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.

The NDA is supported by data from four Phase 3 studies that evaluated the fixed-dose combination among treatment-naïve patients and among virologically suppressed patients.

A marketing application for BIC/FTC/TAF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) in July.

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.



Source: Company Press Release