GALAPAGOS ANNOUNCES POSITIVE CHMP OPINION FOR JYSELECA® (FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
September 17 2021 - 7:15AM
Mechelen,
Belgium; 17
September 2021;
13.15 CET;
Galapagos NV (Euronext & Nasdaq: GLPG)
announced today that
the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) has
issued a positive opinion for
Jyseleca®
(filgotinib), a
once-daily, oral, JAK1
preferential inhibitor for the treatment of adult
patients with moderately to severely
active ulcerative colitis (UC)
who have had an
inadequate response with, lost response to, or were intolerant to
either conventional therapy or a biologic agent.
Following this positive
opinion, a final
decision from the European
Commission is expected
later this year.
The CHMP positive opinion is based on data from
the pivotal Phase 2b/3 SELECTION program, which evaluated
filgotinib as an induction and maintenance therapy in adult
patients with moderately to severely active UC who have failed
conventional therapy or biologics. SELECTION comprised two
placebo-controlled induction studies, one in biologic-naive
patients and the other in biologic-experienced patients, followed
by a 47-week maintenance study for those who responded to
filgotinib after 10 weeks. Responders to placebo continued on
blinded placebo during the maintenance phase. The trial was
recently published in The Lancet1.
Dr Walid Abi-Saab, Chief
Medical Officer at Galapagos, said: “Ulcerative colitis
can have significant and profound effects on the people who suffer
with the condition. Persistent inflammation and uncontrolled
disease mean patients may experience debilitating relapses, may
need increasing doses of steroids and in some instances may require
surgery, which impacts them not only physically, but also
psychologically. Today’s decision brings us one step closer to
providing a new treatment option for people living with this
chronic disease.”
The CHMP positive opinion will now be reviewed
by the European Commission and a decision is expected before year
end 2021. This positive opinion follows the previous approval of
filgotinib for the treatment of patients with moderate to severe
active rheumatoid arthritis. The use of filgotinib for UC is
investigational and is not approved anywhere globally.
About Ulcerative
Colitis Ulcerative colitis (UC) is a
debilitating inflammatory bowel disease (IBD) that occurs as a
result of an abnormal immune system response. Across Europe an
estimated 2 million people2 are affected by IBD, which
includes UC and Crohn’s Disease (CD). UC is a chronic inflammatory
condition of the gastrointestinal (GI) tract. The disease course of
UC is often a state of flare ups and ensuing periods of remission.
In addition to the physical impact from flare ups, there is also a
significant psychological impact associated with UC. It causes
significant impairments on quality of life and a poor prognosis is
often seen in patients with symptoms of moderate to severe UC at
diagnosis.
About
filgotinibFilgotinib is approved and marketed as
Jyseleca (200mg and 100mg tablets) in the European Union, Great
Britain, and Japan for the treatment of adults with moderate to
severe active rheumatoid arthritis (RA) who have responded
inadequately or are intolerant to one or more disease modifying
anti-rheumatic drugs (DMARDs). Filgotinib may be used as
monotherapy or in combination with methotrexate (MTX). The European
Summary of Product Characteristics for filgotinib, which includes
contraindications and special warnings and precautions, is
available at www.ema.europa.eu. The interview form from the
Japanese Ministry of Health, Labour and Welfare is available at
www.info.pmda.go.jp. The individual Great Britain and Northern
Ireland Summary of Product Characteristics can be found at
www.medicines.org.uk/emc and
www.emcmedicines.com/en-GB/northernireland, respectively.
Applications have been submitted to the European Medicines Agency
(EMA), the UK’s Medicines and Healthcare products Regulatory Agency
(MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency
(PMDA) for the treatment of adults with moderately to severely
active ulcerative colitis (UC) who have had an inadequate response
with, lost response to, or were intolerant to either conventional
therapy or a biologic agent and are currently under review.
Filgotinib is not approved in any other countries.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies.
About the
filgotinib collaborationGilead
and Galapagos NV are collaborative partners in the global
development and commercialization of filgotinib. Galapagos will be
responsible for the commercialization of filgotinib in Europe
(transition anticipated to be completed by end of 2021), while
Gilead will remain responsible for filgotinib outside of Europe,
including in Japan, where filgotinib is co-marketed with Eisai.
Filgotinib in UC has been filed in Europe, Great-Britain and Japan,
and a global Phase 3 program is ongoing in Crohn’s Disease. More
information about clinical trials can be accessed at
https://www.clinicaltrials.gov.
About Galapagos Galapagos NV
discovers, develops, and commercializes small molecule medicines
with novel modes of action. 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.
- Feagan. B., et al: Filgotinib as
induction and maintenance therapy for ulcerative colitis: the
SELECTION trial. The Lancet
https://doi.org/10.1016/S0140-6736(21)00666-8.
- Burisch J. et al.
The burden of inflammatory bowel disease in Europe. Journal of
Crohn’s and Colitis (2013) 7, 322-337
Contacts
Investors:Elizabeth GoodwinVP
Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+1 781 296
1143
Sandra CauwenberghsDirector Investor Relations+32 495 58 46
63ir@glpg.com
Media:Anna GibbinsSenior Director Therapeutic
Areas Communications+44 7717 801900
Evelyn FoxDirector Executive Communications +31 65 3591
999 communications@glpg.com
Forward-looking statementsThis
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
forward-looking statements include statements concerning the timing
and outcome of a final decision by the European Commission and
statements concerning the safety, efficacy and commercial potential
of filgotinib. These risks, uncertainties and other factors
include, without limitation, the inherent risks associated with
clinical trial and product development activities, including the
filgotinib clinical program, 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 in UC or other
indications due to safety, efficacy or other reasons, the timing or
likelihood of regulatory authorities approval of marketing
authorization for filgotinib for UC or any other indications, such
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, the timing of
and the risks related to the implementation of the transition of
the European commercialization responsibility of filgotinib from
Gilead to us, as well as those risks and uncertainties identified
in our Annual Report on Form 20-F for the year ended 31 December
2020 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.
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