Jyseleca®▼(filgotinib) approved in the European Union for the
treatment of ulcerative colitis
Mechelen, Belgium; 15
November 2021;
16.45
CET; Galapagos NV (Euronext & Nasdaq:
GLPG) announced today that the European Commission
has granted marketing authorization for
Jyseleca® (filgotinib 200mg
tablets) for the treatment of adult
patients with moderately to severely
active ulcerative colitis
(UC).
The European Commission approved an additional
indication for Jyseleca, an oral, once-daily, JAK1 preferential
inhibitor, for adult patients with moderately to severely active UC
who have had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a biologic agent. The
Commission based its decision on data from the Phase 2b/3 SELECTION
program, which evaluated filgotinib as an induction and maintenance
therapy in the patient population now included in the label. The
SELECTION trial was published in The Lancet1.
“We are very pleased that the European
Commission has approved Jyseleca as a treatment for people with UC.
This decision further supports the efficacy and safety profile of
Jyseleca, which was studied in over 1,250 UC patients. Our focus
now is on making this treatment available as rapidly as possible to
physicians and UC patients across the European Union,” said Onno
van de Stolpe, CEO of Galapagos.
Professor Laurent Peyrin-Biroulet, Professor of
Gastroenterology and Head of the Inflammatory Bowel Disease (IBD)
group at the Gastroenterology Department, University Hospital of
Nancy, France, and Principal Investigator for the SELECTION study,
said: “Despite available treatments for managing UC, there is still
a need for new and innovative therapies like Jyseleca. UC is an
incurable and disabling disease; in severe cases we aim to keep
patients out of hospital and reduce the need for surgical
procedures such as colectomies. Overall, our goals are to manage
the symptoms that have a significant, negative impact on a person’s
overall well-being, to be able to stop the use of steroids and to
improve the daily life of patients. In the SELECTION study we
observed filgotinib’s tablet form was easily administered, provided
significantly greater corticosteroid-free clinical remission from
symptoms compared to placebo and was well tolerated by
patients.”
UC is a life-long condition commonly starting in
late adolescence or early adulthood and characterized by
inflammation of the mucosal lining of the colon and rectum. As an
increasingly prevalent disease, UC has a significant negative
impact on the quality of life of more than 2 million2 people across
Europe. Despite current treatments, many patients experience faecal
urgency, incontinence, recurring bloody diarrhea, the need to empty
their bowels frequently, abdominal pain, poor sleep, and fatigue.
Patients with severe UC can be hospitalized and require life
changing surgery. In addition to the physical symptoms, there is
also a significant psychological impact associated with UC.
Luisa Avendano, CEO at the European Federation
of Crohn’s and Ulcerative Colitis Associations (EFCCA) said: “The
impact that living with UC can have on a person’s life cannot be
underestimated. It is important for each individual to speak to
their doctor about what approach will work best to help them manage
their condition. Having new approved treatment choices is therefore
very important, and at EFCCA we are pleased to see new options
being made available.”
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).
Filgotinib is also approved and marketed as Jyseleca (200mg
tablets) in the European Union for the treatment of adult patients
with moderately to severely active UC who have had an inadequate
response with, lost response to, or were intolerant to either
conventional therapy or a biologic agent. 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 Great Britain Summary of Product
Characteristics for filgotinib can be found at
www.medicines.org.uk/emc and the Northern Ireland Summary of
Product Characteristics for filgotinib can be found at
www.emcmedicines.com/en-GB/northernireland. Applications have been
submitted to 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 UC and are currently under review. A global Phase 3
program with filgotinib is ongoing in Crohn’s Disease. More
information about clinical trials can be accessed at
https://www.clinicaltrials.gov. 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.
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 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, RA, Crohn’s disease or other indications
due to safety or efficacy concerns or other reasons, the timing or
likelihood of regulatory authorities approval of marketing
authorization for filgotinib for other indications, such regulatory
authorities requiring additional studies, the risk that Galapagos
will not be able to continue to execute on its currently
contemplated business plan and/or will need to revise its business
plan, Galapagos’ reliance on collaborations with third parties,
including the collaboration with Gilead for filgotinib, the risk
that Galapagos estimations regarding the commercial potential of
filgotinib may be incorrect, the timing of and the risks related to
the implementation of the transition of the European
commercialization responsibility of filgotinib from Gilead to us,
including the risk that the transition will not be completed on the
currently contemplated timeline or at all, and the risk that the
transition will not have the currently expected results for our
business and results of operations; and, the uncertainties relating
to the impact of the COVID-19 pandemic on our strategy, business
plans and focus, 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.
- Press Release_EU decision UC_ENG_vFINAL for release
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