-- Filgotinib Demonstrates Durable Efficacy
and Consistent Safety Profile Through 52 Weeks in Clinical Trials
--
Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo,
Japan) today announced that the Japanese Ministry of Health, Labour
and Welfare (MHLW) has granted Gilead K.K. (Tokyo, Japan)
regulatory approval of Jyseleca® (filgotinib 200 mg and 100 mg
tablets), a once-daily, oral, JAK1 preferential inhibitor for the
treatment of rheumatoid arthritis (RA) in patients who have had an
inadequate response to conventional therapies, including the
prevention of structural joint damage.
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Gilead Japan will hold the marketing authorization of Jyseleca
in Japan and will be responsible for product supply of Jyseleca in
Japan, while Eisai will be responsible for product distribution of
Jyseleca in Japan in RA. The companies will jointly commercialize
the medicine to make it available to physicians and patients across
Japan.
“Despite progress in the treatment of RA, existing therapies
have not enabled many patients to reach the treatment goals
recommended in clinical guidelines. There continues to be a need
for effective and well-tolerated new treatment options,” said
Tsutomu Takeuchi, MD, Professor of Internal Medicine and Chief of
Rheumatology at the School of Medicine, Keio University. “Jyseleca
is a new JAK inhibitor that, in clinical trials, has demonstrated
clinical improvement, low disease activity and clinical remission
in a broad patient population, including patients with inadequate
response to biologics.”
“RA causes many patients debilitating fatigue and pain that can
significantly interfere with their daily lives,” said Yoshiya
Tanaka, MD, Professor at First Department of Internal Medicine,
University of Occupational and Environmental Health. “It is
important to have new treatment options that can offer patients
effective symptom control and bring them new hope.”
The approval in Japan is based on robust clinical trial results
from the global FINCH Phase 3 and DARWIN Phase 2 programs. The
FINCH and DARWIN programs evaluated Jyseleca in more than 3,500
patients across a range of RA patient populations, including
patients new to treatment and those who have demonstrated
inadequate response to treatment with standard of care including
biologic DMARDs. Patients receiving Jyseleca once daily showed
improvements in clinical signs and symptoms, decreases in disease
activity, and less progression of structural damage in their
joints. Across the FINCH trials, Jyseleca demonstrated a consistent
safety profile, and the frequency of adverse events of interest
(including serious infections, herpes zoster, venous
thromboembolism and major cardiovascular events) was comparable to
control groups.
Across the FINCH and DARWIN trials, the most common adverse
reactions were nausea, upper respiratory tract infection, urinary
tract infection and dizziness. Rates of herpes zoster and pneumonia
were 0.2 percent and 0.3 percent, respectively. The exposure
adjusted incidence rate of serious infections per 100 persons per
year (95 percent CI) was 1.7 percent (1.3, 2.1) in the Jyseleca 200
mg group and 2.5 percent (1.9, 3.3) in the Jyseleca 100 mg group,
respectively. When prescribing Jyseleca, physicians are advised to
monitor patients for the development of new, or exacerbation of
existing, serious infections including pneumonia, tuberculosis,
sepsis and other viral infections.
“This regulatory approval recognizes the benefit that Jyseleca
may be able to provide people living with RA who have not been
successfully treated with prior therapies and represents an
important advance in the treatment of this challenging disease,”
said Luc Hermans, MD, President and Representative Director, Gilead
Sciences, K.K.
“Now that Jyseleca has received approval in Japan, we look
forward to leveraging our extensive experience in clinical
development and commercialization in the RA area in Japan to bring
this new treatment option to patients across Japan as soon as
possible, and contribute to the improvement of patients’ quality of
life,” said Hidenori Yabune, President of Eisai Japan, Senior Vice
President, Eisai.
Gilead is developing Jyseleca in collaboration with Galapagos NV
(Mechelen, Belgium (Nasdaq and EuroNext: GLPG)). The two companies
are conducting global studies investigating the potential role of
Jyseleca in a variety of diseases, including the previously
reported Phase 3 SELECTION trial in ulcerative colitis.
About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety
of filgotinib 100 mg and 200 mg once-daily, in RA patient
populations ranging from early stage to biologic-experienced
patients. FINCH 1 was a 52-week, randomized, placebo- and
adalimumab-controlled trial in combination with MTX, enrolling
1,759 adult patients with moderately to severely active RA who had
inadequate response to MTX. The primary endpoint in FINCH 1 was
ACR20 at Week 12. The trial included radiographic assessment at
Weeks 24 and 52. FINCH 2 was a global, 24-week randomized,
double-blind, placebo-controlled, Phase 3 study evaluating
filgotinib on a background of conventional synthetic
disease-modifying anti-rheumatic drug(s) (csDMARDs) among 449 adult
patients with moderately to severely active RA who had not
adequately responded to biologic DMARDs (bDMARDs). The primary
endpoint in FINCH 2 was ACR20 at Week 12. FINCH 3 was a 52-week,
randomized trial in 1,252 MTX-naïve patients to evaluate filgotinib
200 mg alone and filgotinib 100 mg or 200 mg combined with MTX
versus MTX alone. The primary endpoint in FINCH 3 was ACR20 at Week
24. The trial included radiographic assessment at Weeks 24 and
52.
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/.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and
development-based pharmaceutical company headquartered in Japan. We
define our corporate mission as "giving first thought to patients
and their families and to increasing the benefits health care
provides," which we call our human health care (hhc) philosophy.
With approximately 10,000 employees working across our global
network of R&D facilities, manufacturing sites and marketing
subsidiaries, we strive to realize our hhc philosophy by delivering
innovative products to address unmet medical needs, with a
particular focus in our strategic areas of Neurology and Oncology.
As a global pharmaceutical company, our mission extends to patients
around the world through our investment and participation in
partnership-based initiatives to improve access to medicines in
developing and emerging countries.
For more information about Eisai Co., Ltd., please visit
https://www.eisai.com.
Gilead Forward-Looking
Statements
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 Jyseleca may not be successfully
commercialized for the treatment of rheumatoid arthritis in Japan.
There is also the possibility of unfavorable results from ongoing
and additional clinical trials involving Jyseleca and the risk that
other regulatory authorities may not approve Jyseleca for the
treatment of rheumatoid arthritis and other indications, and any
marketing approvals, if granted, may have significant limitations
on its use. Further, it is possible that Gilead may make a
strategic decision to discontinue development and commercialization
of Jyseleca, and as a result, Jyseleca may never be successfully
commercialized. 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, 2020, 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.
Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead
Sciences, Inc. or its related companies.
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