Gilead Submits Filgotinib New Drug Application to U.S. Food & Drug Administration Under Priority Review for Rheumatoid Arthri...
December 19 2019 - 4:30PM
Business Wire
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for filgotinib, an investigational, oral,
selective JAK1 inhibitor for the treatment of adults who are living
with moderate-to-severe rheumatoid arthritis (RA). A priority
review voucher was submitted with the NDA, shortening the
anticipated time for review.
The filing is supported by 52-week data from the global Phase 3
FINCH clinical program, which evaluated the efficacy and safety of
filgotinib in 3,452 patients with moderate to severely active RA.
In the FINCH studies, filgotinib met its primary endpoints and
demonstrated durable efficacy and safety results across multiple RA
patient populations, including in people with prior inadequate
response to methotrexate treatment (MTX), those who were intolerant
to one or more biologic treatments and those who were MTX
treatment-naïve. Safety results were consistent across the trials
and further reinforce the long-term safety and tolerability profile
of filgotinib for a broad range of RA patients.
Despite the availability of current therapies, people living
with RA may face persistent disease symptoms and inadequate
responses to currently available therapies. One in five patients do
not achieve complete disease remission during their lifetimes and
remain in need of treatment options.
“The new drug application submission for filgotinib represents
an important step forward in bringing a potential new treatment
option to people living with RA,” said Merdad Parsey, MD, PhD,
Chief Medical Officer, Gilead Sciences. “In clinical trials,
filgotinib has demonstrated an efficacy and tolerability profile
that may offer meaningful improvements in RA treatment response for
patients with this chronic, debilitating disease.”
This filing is the third regulatory agency submission for
filgotinib in the past five months following submissions to the
European Medicines Agency and Japanese Ministry of Health, Labor
and Welfare earlier this year.
Filgotinib is an investigational agent and is not approved by
any regulatory authority. Its efficacy and safety have not been
established.
About the Filgotinib
Collaborationi
Gilead and Galapagos NV are collaborative partners in the global
development and commercialization of filgotinib in RA, and other
potential inflammatory indications. In the United States, Gilead is
solely responsible for the commercialization of filgotinib, pending
approval of filgotinib by the FDA.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Gilead 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 of unfavorable results from ongoing and
additional clinical trials involving filgotinib and the possibility
that we may be unable to complete one or more of such trials in the
currently anticipated timelines or at all. Further, it is possible
that the parties may make a strategic decision to discontinue
development of filgotinib, and as a result, filgotinib may never be
successfully commercialized. All statements other than statements
of historical fact are statements that could be deemed
forward-looking statements. 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 September 30, 2019, 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.
__________________
i Gilead & Galapagos Filgotinib Clinical Program Trial
Details: SELECTION (NCT02914522); DIVERSITY (NCT02914561); PENGUIN
1 (NCT04115748); PENGUIN 2 (NCT04115839)
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Greg Mann, Investors (424) 322-1795
Arran Attridge, Media (650) 425-8975
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