Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine & Tenofovir Al...
August 10 2017 - 4:01PM
Business Wire
-- Final FDA Decision Anticipated by
February 12, 2018 --
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
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.
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.
Forward-Looking
Statement
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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Gilead Sciences, Inc.Sung Lee, 650-524-7792 (Investors)Kelsey
Grossman, 650-378-2103 (Media)
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