Gilead Submits New Drug Application to U.S. Food & Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabi...
June 12 2017 - 8:15AM
Business Wire
– Investigational Single Tablet Regimen May
Have Potential to Advance Triple-therapy HIV Treatment for a Broad
Range of Patients –
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 protease inhibitor.
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.
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 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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Gilead Sciences, Inc.Sung Lee, 650-524-7792 (Investors)Ryan
McKeel, 650-377-3548 (Media)
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