August 10, 2017
Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
-- Final FDA Decision Anticipated by February 12, 2018 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 10, 2017--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food
and Drug Administration (FDA) has granted priority review for the
company’s New Drug Application (NDA) for an investigational, fixed-dose
combination of bictegravir (50mg) (BIC), a novel investigational
integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir
alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, 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
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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.
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 the
possibility that FDA and other regulatory authorities may not approve
BIC/FTC/TAF in the currently anticipated timelines or at all, and any
marketing approvals, if granted, may have significant limitations on
their use. As a result, BIC/FTC/TAF may never be successfully
commercialized. 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
June 30, 2017, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Grossman, 650-378-2103 (Media)