Gilead Sciences Submits New Drug Application for Filgotinib for the Treatment of Adults With Rheumatoid Arthritis in Japan
October 08 2019 - 2:00AM
Business Wire
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the
New Drug Application (NDA) for filgotinib, an investigational,
oral, selective JAK1 inhibitor for the treatment of adults with
rheumatoid arthritis (RA) has been submitted to the Japanese
Ministry of Health, Labor and Welfare (MHLW).
The NDA for filgotinib is supported by data from the Phase 3
FINCH clinical trial program in which once-daily treatment with
filgotinib demonstrated the potential to improve clinical signs and
symptoms, to achieve low disease activity and remission, and to
inhibit structural damage for patients living with RA. Safety data
across the FINCH clinical trial program was consistent with
previously reported results.
“Despite multiple medications currently available to treat
rheumatoid arthritis, there are still far too many people who do
not experience adequate relief from their symptoms,” said John
Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory
Diseases, Gilead Sciences. “The FINCH clinical trial program
demonstrated that filgotinib may offer a wide range of people
living with RA, including those in the early treatment and those
who have tried standard therapies without success, an important new
treatment option.”
“This new drug application is an important milestone as we
continue to expand Gilead’s presence in Japan to now also include
inflammation,” said Luc Hermans, MD, President and Representative
Director, Gilead Sciences, K.K. “We are committed to bringing
innovative products to patients and healthcare providers in Japan,
expanding beyond antivirals into new areas where our medicines can
make a meaningful difference to patients.”
There are estimated to be up to one million people living with
RA in Japan.
Filgotinib is an investigational agent and is not approved
anywhere globally. Its efficacy and safety have not been
established by any regulatory authorities.
About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety
of 100 mg and 200 mg filgotinib once daily, in RA patient
populations ranging from early stage to biologic-experienced
patients. FINCH 1 is a 52-week, randomized, placebo- and
adalimumab-controlled trial in combination with methotrexate (MTX)
that enrolled 1,759 adult patients with moderately to severely
active RA who have had an inadequate response to MTX. The primary
endpoint was ACR20 at week 12. The trial included radiographic
assessment at weeks 24 and 52. FINCH 2 was a 24-week, randomized,
placebo-controlled trial in 449 patients who were receiving
conventional disease-modifying anti-rheumatic drugs (cDMARD) and
had a prior inadequate response to one or more biological
therapies. The primary endpoint was ACR20 at week 12. FINCH 3 is a
52-week, randomized trial in 1,252 MTX-naïve patients to study
filgotinib in combination with MTX, as well as monotherapy. The
primary endpoint was ACR20 at week 24. Radiographic progression was
also assessed.
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.
For more information on Gilead Sciences K.K., please visit the
company’s website at https://www.gilead.co.jp/.
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 risk that the MHLW and other regulatory agencies may
not approve filgotinib for the treatment of RA, and any marketing
approvals, if granted, may have significant limitations on its use.
As a result, filgotinib may never be successfully commercialized.
Further, there is the possibility of unfavorable results from
ongoing and additional clinical trials involving filgotinib. 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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20191007005875/en/
Sung Lee, Investors (650) 524-7792
Seiko Noma, Media, Japan +81 3 6837 0790
Arran Attridge, Media, US (650) 425-8975
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