European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Bictegravir, Emtricitabine...
July 13 2017 - 6:57AM
Business Wire
– EMA MAA Validation Follows Submission of
NDA for BIC/FTC/TAF to the U.S. FDA –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the
company’s Marketing Authorization Application (MAA) for an
investigational, once-daily single tablet regimen containing
bictegravir (50 mg; BIC), a novel investigational integrase strand
transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide
(200/25mg; FTC/TAF) for the treatment of HIV-1 infection in adults
has been fully validated and is now under evaluation by the
European Medicines Agency (EMA).
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.
“This investigational single tablet regimen represents a
potential advance in HIV treatment by combining the potency of an
integrase inhibitor, bictegravir, with the demonstrated safety
profile of the FTC/TAF backbone,” said Norbert Bischofberger, PhD,
Executive Vice President, Research and Development and Chief
Scientific Officer, Gilead Sciences. “Gilead remains at the
forefront of driving innovation in HIV, with our continued
commitment to working to simplify and improve treatments for people
living with HIV.”
The MAA for BIC/FTC/TAF is supported by data from four Phase 3
studies in which the regimen met its primary objective of
non-inferiority at 48 weeks. 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; DTG); two
in treatment-naïve patients and one in virologically suppressed
patients (HIV-1 RNA levels <50 copies/mL) switching from an
existing DTG-containing antiretroviral regimen. 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.
The BIC/FTC/TAF filing will be reviewed by the EMA under the
centralized licensing procedure for all 28 member states of the
European Union, as well as Norway and Iceland.
Gilead submitted a New Drug Application (NDA) for BIC/FTC/TAF in
the United States on June 12, 2017, and 48-week data from two Phase
3 studies investigating BIC/FTC/TAF compared to regimens containing
DTG in treatment-naïve adult patients will be presented at the
International AIDS Society Conference on HIV Science (IAS 2017),
July 23-26, 2017, in Paris.
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 EMA and other regulatory agencies may not approve
BIC/FTC/TAF, and any marketing approvals, if granted, may have
significant limitations on its use. 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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version on businesswire.com: http://www.businesswire.com/news/home/20170713005472/en/
Gilead Sciences, Inc.Investors (US)Sung Lee, +1
650-524-7792orMedia (US)Ryan McKeel, +1 650-377-3548orMedia
(EU)Stephen Head, +44 (0)7768 705945
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