EUROPEAN COMMISSION GRANTS MARKETING
AUTHORIZATION FOR JYSELECA® (FILGOTINIB) FOR
THE TREATMENT OF ADULTS WITH
MODERATE TO SEVERE ACTIVE RHEUMATHOID
ARTHRITIS
-- Jyseleca®
Demonstrated Durable Efficacy Combined with a
Consistent Safety Profile in Rheumatoid Arthritis Through 52 Weeks
in Phase 3 Clinical Development Program
--
Foster City, Calif., & Mechelen,
Belgium, September 25, 2020, 19.00 CET – 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
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 more
than 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.7-8910111213
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.7-13
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 with 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 percent compared
with 0.6 percent 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.”
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.
About the FINCH ProgramThe
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
Collaboration15Gilead 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.
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
StatementThis 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
StatementThis 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 inherent risks associated with
clinical trial and product development activities, competitive
developments, and regulatory approval requirements, including the
risk that data from the ongoing and planned clinical research
programs with filgotinib may not support registration or further
development due to safety, efficacy or other reasons, the timing or
likelihood of additional regulatory authorities approval of
marketing authorization for filgotinib, such additional regulatory
authorities requiring additional studies, Galapagos’ reliance on
collaborations with third parties, including the collaboration with
Gilead for filgotinib, the uncertainty regarding estimates of the
commercial potential of filgotinib, 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.
Contacts Galapagos
Investors:
Media:Elizabeth
Goodwin
Carmen Vroonen VP
IR
Global Head of Communications & Public Affairs+1 781 460
1784
+32 473 824
874
Sofie Van Gijsel
Anna GibbinsSenior Director IR
Senior Communications Director – Therapeutic Areas+32 485 19 14
15
+44 (0) 7717
801900ir@glpg.com
communications@glpg.com
Contacts
GileadInvestors:
Media:Douglas Maffei,
PhD
Jennifer Wilson+1 650
522-2739
+44 7920 266-582
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).
- EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR JYSELECA
(FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE
ACTIVE RHEUMATOID ARTHRITIS (002)
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