June 12, 2017
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment
– Investigational Single Tablet Regimen May Have Potential to
Advance Triple-therapy HIV Treatment for a Broad Range of Patients –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 12, 2017--
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for an investigational, once-daily single tablet
regimen containing bictegravir (50 mg) (BIC), a novel investigational
integrase strand transfer inhibitor, and emtricitabine/tenofovir
alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection
in adults. 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.
“We aim to simplify the management of HIV for a broad range of patients
with this single tablet regimen that combines the potency of an
integrase inhibitor, bictegravir, and the demonstrated long-term safety
profile of the FTC/TAF backbone,” said Norbert Bischofberger, PhD,
Executive Vice President, Research and Development and Chief Scientific
Officer, Gilead Sciences. “This regulatory filing is a demonstration of
Gilead’s ongoing commitment to bringing forward treatment innovations
that have the potential to address the needs of patients and physicians.”
The NDA for BIC/FTC/TAF is supported by data from four Phase 3 studies
in which the regimen met its primary objective of non-inferiority. 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) among treatment-naïve patients and among
virologically suppressed patients (HIV-1 RNA levels <50 copies/mL)
switching from an existing antiretroviral regimen with dolutegravir. 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
Gilead plans to submit a marketing authorization application for
BIC/FTC/TAF in the European Union in the third quarter of 2017.
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 FDA and
other regulatory agencies may not approve BIC/FTC/TAF, and any marketing
approvals, if granted, may have significant limitations on its use. In
addition, there are risks associated with Gilead’s ability to submit its
regulatory application for BIC/FTC/TAF in the European Union in the
currently anticipated timeline. 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 March 31, 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)
McKeel, 650-377-3548 (Media)