NOT FOR DISTRIBUTION IN THE UNITED
KINGDOM
- NICE guidance, for the first time in the UK, supports
access to an advanced therapy for people with moderate as well as
severe rheumatoid arthritis (RA) - aiming to avoid irreversible
damage as early as possible1
- More than 400,000 people across the UK live with
RA2 and around 70% have moderate or severe
disease3
Mechelen, Belgium, 21 January 2021,
08:05 CET – Galapagos NV (Euronext & Nasdaq:
GLPG) today welcomed the news that the National Institute for
Health and Care Excellence (NICE) has issued a final appraisal
determination (FAD) recommending the use of the daily oral pill,
JYSELECA®▼ (filgotinib) on the National Health
Service (NHS) in England for the treatment of eligible adult
patients with moderate to severe active rheumatoid arthritis (RA).1
It is the first time in the UK that an advanced therapy has been
recommended in people with moderate RA, offering thousands more the
potential to achieve remission earlier - potentially slowing the
irreversible damage and life-limiting symptoms RA can cause.2 RA is
a degenerative auto-immune disease that can cause life-threatening
complications.4 The sooner treatment begins, the better the
chance of slowing disease progression.2 With thousands of people
potentially eligible, the recommendation could help improve many
lives as well as lessen the significant societal burden RA has in
England.5,6
“We are delighted with the NICE
recommendation for Jyseleca today. For patients with moderate to
severe RA in England this decision represents a significant new
opportunity and especially for those with moderate symptoms who can
now receive an advanced treatment earlier,” said Onno van de
Stolpe, Galapagos CEO.
Filgotinib is a once daily oral pill that can be
given on its own (as a monotherapy) or used alongside another
common RA medicine, called methotrexate.7 Eligible patients with
moderate or severe RA will have responded inadequately to intensive
therapy with 2 or more conventional disease-modifying antirheumatic
drugs (DMARDs).1 Eligible patients with severe disease will also
have wider access to filgotinib in line with criteria defined by
NICE. Filgotinib is an advanced therapy which, in RA, is a term
used to describe biologic DMARDs and targeted synthetic
DMARDs.1
More than 400,000 people in the UK live with RA
(around 380,000 in England), and it is recognised as a condition
that can cause debilitating physical pain, affect mental health and
require chronic care.2 Studies have shown that RA shortens life
expectancy, with some estimates putting this at around 10 years.8
Nearly 50% of patients diagnosed with RA suffer from mental health
issues with 1 in 6 people having a major depressive disorder.6,9 RA
is also a significant burden on the UK economy. Around a third of
people diagnosed with RA stop work within two years of diagnosis10
and the combined cost of workdays lost due to osteoarthritis and RA
in the UK was estimated at £2.58 billion in 2017 – estimated to
rise to £3.43 billion by 2030.5
NICE guidance covers England. Wales and Northern
Ireland are expected to follow the guidance with timelines for
implementation currently under consideration. Filgotinib will be
reviewed separately by the Scottish Medicines Consortium for use on
the NHS in Scotland.
Under a new arrangement between Gilead and
Galapagos, announced in December 2020, Galapagos will assume sole
responsibility for filgotinib in Europe, including the UK. Through
a phased transition the majority of activities supporting
filgotinib in Europe are expected to be assumed by Galapagos by the
end of 2021.
About
filgotinib7Filgotinib is a Janus-kinase
(JAK) inhibitor and works by preferentially targeting JAK1, part of
a specific pathway involved in inflammation – an immune response of
the body that causes symptoms of RA. In clinical studies,
filgotinib has been shown to significantly improve the chance of
disease remission (a DAS28-CRP score of <2.6, indicating few or
no symptoms).7 In the FINCH 1 study of 1,755 patients with RA who
had an inadequate response to methotrexate, 34% of patients given
filgotinib 200mg + methotrexate (n=475) achieved disease remission
after just 12 weeks, compared to 9% of a group given placebo
(n=475). After 24 weeks, 48% of patients in this group had achieved
remission vs. 16% of those on placebo and these response levels
were sustained through 52 weeks. In many cases, responses were seen
within two weeks (measured using an ACR20 score).
Data supporting filgotinib include more than
3,800 patients treated across the Phase 3 FINCH and Phase 2 DARWIN
programmes. In the FINCH studies, filgotinib consistently achieved
ACR20/50/70 criteria, with improvements in all individual ACR
components compared with placebo or methotrexate.
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 uncommon. The frequency of serious
infections in the filgotinib 200mg group was 1.0 percent compared
with 0.6 percent in the placebo group. In an integrated safety
analysis in seven clinical trials the rates of major adverse
cardiac events (MACE) and venous thromboembolism (VTE) with
filgotinib were comparable to placebo. The rates of serious
infections remained stable with long-term exposure.
About GalapagosGalapagos NV
discovers and develops small molecule medicines with novel modes of
action, several 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 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.
Except for filgotinib's approval for the
treatment of RA by the European Commission and Japanese
Ministry of Health, Labour and Welfare, our drug candidates
are investigational; their efficacy and safety have not been
fully evaluated by any regulatory authority and they are
not yet approved for any use outside of clinical trials.
Galapagos Forward-Looking Statements
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 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, the timing or likelihood
of additional guidance or final appraisal determinations for
filgotinib, Galapagos’ reliance on collaborations with third
parties, including the collaboration with Gilead for filgotinib,
the uncertainty regarding estimates of the commercial potential of
filgotinib, the timing of and the risks related to completing and
implementing the amendment of our arrangement with Gilead for the
commercialization and development of Jyseleca (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.
Jyseleca®, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc. or its related companies.
CONTACTS:
Investors:
Elizabeth
Goodwin
VP Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+32 485 19 14
15ir@glpg.com
Media:Carmen VroonenGlobal Head of
Communications & Public Affairs+32 473 824 874
Anna GibbinsSenior Communications Director+44 (0) 7717
801900mailto:communications@glpg.com
▼ The black triangle next to JYSELECA® means
that it is subject to additional monitoring. This is to allow quick
identification of new safety information. Patients can help with
this by reporting any side effects that they experience. More
information can be found online at
https://www.mhra.gov.uk/yellowcard
References1 National Institute for Health and
Care Excellence. Filgotinib for treating moderate to severe
rheumatoid arthritis ID1632. Available at:
https://www.nice.org.uk/guidance/proposed/gid-ta10541. Accessed:
January 2021
2 National Rheumatoid Arthritis Society. What is RA? Available
at https://www.nras.org.uk/what-is-ra-article Accessed: January
20213 Data on file. Gilead Science Ltd. UK-INF-2020-09-00254 NHS.
(2019). Rheumatoid Arthritis. Available:
https://www.nhs.uk/conditions/rheumatoid-arthritis/ Accessed
January 2021.5 Versus Arthritis, 2019. The State of Musculoskeletal
Health 2019. Available
at:https://www.versusarthritis.org/media/14594/state-of-musculoskeletal-health-2019.pdf
Accessed: January 20216 Versus Arthritis. Versus Arthritis
representation to the Budget 2018. September 2018. Key fact
available
athttps://www.versusarthritis.org/media/1996/versus-arthritis-response-budget-2018pdf.pdf
Accessed: January 20217 Filgotinib summary of product
characteristics. Available at Jyseleca, INN-filgotinib (europa.eu)
Accessed January 2021.8 NRAS – How Is life expectancy affected by
RA? Available at NRAS - National Rheumatoid Arthritis Society
Accessed: January 20219 KCL. (2018). Mental health linked to
disease flare of patients with rheumatoid arthritis. Available:
https://www.kcl.ac.uk/news/mental-health-linked-to-disease-flare-of-patients-with-rheumatoid-arthritis-3
Accessed January 2021.10 NICE. (2018). Rheumatoid arthritis in
adults: management. Available:
https://www.nice.org.uk/guidance/ng100/resources/rheumatoid-arthritis-in-adults-management-pdf-66141531233989
Accessed January 2021.
- NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark
decision for rheumatoid arthritis
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