-- Jyseleca® Demonstrated Durable
Efficacy Combined with a Consistent Safety Profile in Rheumatoid
Arthritis Through 52 Weeks in Phase 3 Clinical Development Program
--
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& Nasdaq: GLPG) today announced that the European Commission
(EC) has granted marketing authorization for Jyseleca® (filgotinib
200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for
the treatment of adults with moderate to severe active rheumatoid
arthritis (RA) who have responded inadequately to, or are
intolerant to, one or more disease modifying anti-rheumatic drugs
(DMARDs). Jyseleca may be used as monotherapy or in combination
with methotrexate (MTX).1
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RA is a chronic, progressive, systemic, inflammatory disease
that can lead to significant and irreversible joint destruction,
pain and functional impairment.2 Almost 3 million people in Europe
are living with RA,3 many of whom do not achieve long-term symptom
control, which can lead to more frequent symptom flares and disease
progression and can significantly impact their quality of
life.4,5
“Despite the availability of existing therapies, new treatment
options are still needed to help optimally manage the impact of RA
on patients’ daily lives. Jyseleca has demonstrated robust symptom
control and prevention of disease progression with a consistent
safety profile across the clinical development program. This
marketing authorization provides a welcome new option for people in
Europe living with this debilitating and complex disease,” said
Peter C. Taylor, MA, BM, BCh, PhD, FRCP, Professor of
Musculoskeletal Sciences at the University of Oxford.
The EC’s decision is supported by data from over 3,500 patients
treated with Jyseleca across the Phase 3 FINCH and Phase 2 DARWIN
programs.6 In the FINCH studies, Jyseleca consistently achieved
ACR20/50/70 criteria, with improvements in all individual ACR
components compared with placebo or MTX.7-13
A significantly higher proportion of patients treated with
Jyseleca 200 mg plus MTX or other conventional synthetic
disease-modifying anti-rheumatic drug(s) (csDMARD) achieved low
disease activity and/or remission (DAS28-CRP≤3.2 and
DAS28-CRP<2.6) at Weeks 12 and 24 compared with placebo or
MTX.6-12
In patients who had an inadequate response to MTX, treatment
with Jyseleca plus MTX achieved statistically significant
inhibition of progression of structural joint damage compared to
placebo plus MTX, as assessed using the modified Total Sharp Score
(mTSS) at Week 24. In the DARWIN 3 Phase 2, open-label, long-term
extension study, durable ACR20/50/70 responses were maintained for
up to three years in patients who received Jyseleca 200 mg as
monotherapy or with MTX.1
Across the FINCH and DARWIN trials,14 the most common adverse
reactions were nausea, upper respiratory tract infection, urinary
tract infection and dizziness.1 Rates of herpes zoster and
pneumonia were uncommon.1 The frequency of serious infections in
the Jyseleca 200 mg group was 1.0% compared to 0.6% in the placebo
group.1
In an integrated safety analysis in seven clinical trials the
rates of major adverse cardiac events (MACE) and venous
thromboembolism (VTE) with Jyseleca were comparable to placebo.6
The rates of serious infections remained stable with long-term
exposure.1
“Jyseleca, the first medicine from Galapagos to obtain
regulatory approval is the result of a strong commitment to
addressing unmet medical need,” said Daniel O’Day, Chairman and
Chief Executive Officer, Gilead Sciences. “We look forward to
making continued progress through our collaboration with Galapagos
so we can help to deliver many new solutions for patients in the
future.”
“Today’s announcement is a proud day for everyone at Galapagos,
recognizing years of research and commitment to make a meaningful
change in the lives of patients struggling with the symptoms of
RA,” said Onno van de Stolpe, Chief Executive Officer, Galapagos.
“This news further affirms the efficacy and safety profile of
Jyseleca, and we look forward to bringing this important treatment
to physicians and patients across Europe as quickly as
possible.”
About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety
of Jyseleca 200 mg and 100 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
moderate to severe 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 12, 24 and 52. FINCH 2
was a global, 24-week, randomized, double-blind,
placebo-controlled, Phase 3 study evaluating Jyseleca on a
background of csDMARDs among 449 adult patients with moderate to
severe 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 Jyseleca 200 mg alone and Jyseleca 200 mg or
100 mg combined with MTX versus MTX alone in MTX-naïve patients.
The primary endpoint in FINCH 3 was ACR20 at Week 24. The trial
included radiographic assessment at Weeks 24 and 52.
About the Filgotinib
Collaboration15
Gilead and Galapagos NV are collaborative partners in the global
development and commercialization of filgotinib in RA and other
inflammatory indications. The 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.
Under the collaboration agreement, Galapagos will now receive a
milestone payment of $75 million in recognition of the approval of
Jyseleca by the European Commission.
More information about clinical trials with Jyseleca can be
accessed at: www.clinicaltrials.gov.
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.
About Galapagos
Galapagos NV discovers and develops small molecule medicines
with novel modes of action, three of which show promising patient
results and are currently in late-stage development in multiple
diseases. Our pipeline comprises discovery through Phase 3 programs
in inflammation, fibrosis, osteoarthritis and other indications.
Our ambition is to become a leading global biopharmaceutical
company focused on the discovery, development and commercialization
of innovative medicines. More information at www.glpg.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. There
is also the possibility of unfavorable results from ongoing and
additional clinical trials involving filgotinib. 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 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.
Galapagos Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, that are subject to risks, uncertainties and
other factors that could cause actual results to differ materially
from those referred to in the forward-looking statements and,
therefore, the reader should not place undue reliance on them.
These risks, uncertainties and other factors include, without
limitation, the risk that ongoing and future clinical studies with
filgotinib may not be completed in the currently envisaged
timelines or at all, the inherent uncertainties associated with
competitive developments, clinical trial and product development
activities, regulatory approval requirements and the timing and
outcome of interactions with regulatory authorities (including that
data from the ongoing and planned clinical research programs may
not support registration or further development of filgotinib due
to safety, efficacy or other reasons), Galapagos' reliance on
collaborations with third parties (including our collaboration
partner for filgotinib, Gilead) and that Galapagos’ estimations
regarding its filgotinib development program and regarding the
commercial potential of filgotinib may be incorrect, as well as
those risks and uncertainties identified in our Annual Report on
Form 20-F for the year ended 31 December 2019 and our subsequent
filings with the SEC. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The forward-looking statements contained herein are
based on management’s current expectations and beliefs and speak
only as of the date hereof, and Galapagos makes no commitment to
update or publicly release any revisions to forward-looking
statements in order to reflect new information or subsequent
events, circumstances or changes in expectations.
Full European Summary of Product
Characteristics for Jyseleca are available from the EMA website at
www.ema.europa.eu.
Jyseleca®, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc. or its related companies.
1Summary of Product Characteristics for Jyseleca®, Foster City,
USA: Gilead Sciences.
2Centers for Disease Control and Prevention. Rheumatoid
Arthritis (RA). Available at:
https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html.
Accessed: September 2020.
3National Rheumatoid Arthritis Society (NRAS). European Fit for
Work report. Available at:
https://www.nras.org.uk/european-fit-for-work-report. Accessed:
September 2020.
4Claxton, L. et al. An economic evaluation of tofacitinib
treatment in rheumatoid arthritis after methotrexate or after 1 or
2 TNF inhibitors from a US payer perspective. Journal of Managed
Care & Specialty Pharmacy. 2018;13:1-8. doi:
10.18553/jmcp.2018.17220.
5Smolen, J.S. et al. EULAR recommendations for the management of
rheumatoid arthritis with synthetic and biological
disease-modifying antirheumatic drugs: 2016 update. Annals of
Rheumatic Disease. 2017;79:685-699. doi:
10.1136/annrheumdis-2019-216655.
6Genovese, M C et al. Integrated safety Analysis of Filgotinib
Treatment for Rheumatoid Arthritis from 7 Clinical Trials. Abstract
European Congress of Rheumatology (EULAR) 2020.
7Kivitz, A. et al. Filgotinib provided rapid and sustained
improvements in functional status, pain, health-related quality of
life, and fatigue in patients with rheumatoid arthritis and
inadequate response to methotrexate: results from the FINCH 1
study. Abstract European Congress of Rheumatology (EULAR) 2020.
8Combe, B. et al. Efficacy and safety of Filgotinib for patients
with rheumatoid arthritis with inadequate response to methotrexate:
FINCH 1 52-week results. Abstract ACR/ARP Annual Meeting 2019.
9Combe, B. et al. LB0001 efficacy and safety of Filgotinib for
patients with rheumatoid arthritis with inadequate response to
methotrexate: FINCH 1 primary outcome results. Annals of the
Rheumatic Diseases. 2019;78:77-78.
10Genovese, M. et al. Effect of Filgotinib vs placebo on
clinical response in patients with moderate to severe rheumatoid
arthritis refractory to disease-modifying antirheumatic drug
therapy: the FINCH 2 randomized clinical trial [published
correction appears in JAMA. 2020 Feb 4;323(5):480]. JAMA.
2019;322(4):315‐325. doi:10.1001/jama.2019.9055.
11Westhovens, R. et al. Efficacy and safety of Filgotinib in
methotrexate-naïve patients with rheumatoid arthritis: FINCH 3
52-week results, Annals of the Rheumatic Diseases
2020;79:1019-1020.
12Alten, R. et al. Filgotinib provided rapid and sustained
improvements in functional status, pain, and health related quality
of life, and reduced fatigue over time in patients with rheumatoid
arthritis who are methotrexate-naïve: results from the FINCH 3
study. Abstract European Congress of Rheumatology (EULAR) 2020.
13Westhovens, R. et al. LB0003 efficacy and safety of Filgotinib
for patients with rheumatoid arthritis naïve to methotrexate
therapy: FINCH 3 primary outcome results. Annals of the Rheumatic
Diseases. 2019;78:259-261.
14Frequency based on placebo controlled pre rescue period (week
12) pooled across FINCH 1 and 2, and DARWIN 1 and 2, for patients
who received Filgotinib 200 mg. Summary of Product Characteristics
for Jyseleca® (table 2). Foster City, USA: Gilead Sciences.
15 Gilead & Galapagos Filgotinib Clinical Program Trial
Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3
(NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561);
PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839).
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Gilead Douglas Maffei, PhD, Investors +1 (650)
522-2739
Jennifer Wilson, Media - Europe +44 7920 266-582
Arran Attridge, Media - US +1 (650) 425-8975
Galapagos Elizabeth Goodwin, Investors +1 (781)
460-1784
Carmen Vroonen, Media +32 473 824-874
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