Mechelen, Belgium;
18 January
2022;
22.01
CET; Galapagos NV (Euronext &
Nasdaq: GLPG) announced today that the Medicines and Healthcare
products Regulatory Agency (MHRA) has granted a
marketing authorization for
Jyseleca® (filgotinib
200mg tablets), as a new treatment for ulcerative
colitis (UC) for Great
Britain.
The MHRA has licensed an additional indication
for Jyseleca, an oral once-daily, JAK1 preferential inhibitor, for
use in 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
submission was supported by data from the Phase 2b/3 SELECTION
program, published in the Lancet1. The decision from the MHRA
follows authorisation from the European Commission (EC) for use in
the same patient population.
Michele Manto, Chief Commercial Officer at
Galapagos said: “At Galapagos we are committed to bringing new and
innovative medicines to healthcare professionals who are treating
patients with UC and today we are one step closer to offering a new
treatment option to thousands of patients living in Great Britain
with UC, a chronic and debilitating disease. Together with the EC
decision, this decision represents an important milestone in our
plans to make Jyseleca available to eligible adult patients with UC
across Europe.”
Dr Ian Beales, Consultant in Gastroenterology
and General Medicine, Norfolk and Norwich University Hospital and
Chief Investigator for the SELECTION study in the UK
said: “The prevalence of UC in the UK is increasing. 1 in
every 420 people are currently estimated to have the disease.
Despite available treatments there is still a need for innovative
new therapies to provide relief from the symptoms that can have
debilitating physical consequences for patients. In the SELECTION
study when compared to placebo, more patients on filgotinib 200mg
demonstrated corticosteroid-free remission from clinical symptoms
with improvements in measures of health-related quality of life and
was well-tolerated by patients. We welcome having a new treatment
option available to help us with managing this disease.”
UC is a life-long condition characterized by
inflammation of the mucosal lining of the colon and rectum. Current
estimates suggest that in the UK more than 146,0002 people are
currently living with UC. The prevalence of inflammatory bowel
diseases, which includes UC, is rising in the UK with peak
diagnosis in late adolescence or early adulthood3.
Ruth Wakeman, Director of Services, Advocacy
& Evidence, Crohn’s & Colitis UK, said: “Ulcerative Colitis
can be an extremely debilitating condition, affecting many parts of
the body and many aspects of life. It can affect people in
very individual ways, so effective and appropriate treatment based
on personalized care and shared decision making is really
important. For some people with UC, existing treatments may
not work, so additional treatment options are welcome.”
About filgotinib Filgotinib is
licensed and marketed as Jyseleca (200mg and 100mg tablets) in
Great Britain, the European Union 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 licensed and marketed as Jyseleca in Great
Britain and the European Union for the treatment of adult patients
with moderately to severely active ulcerative colitis who have had
an inadequate response with, lost response to, or were intolerant
to either conventional therapy or a biologic agent. An application
has been submitted to the Japan’s Pharmaceuticals and Medical
Devices Agency (PMDA) for the treatment of adults with moderately
to severely active UC and is currently under review. 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. 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. 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.
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 is responsible for the commercialization of
filgotinib in Europe, while Gilead remains 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.
1. Feagan. B., et al: Filgotinib as induction
and maintenance therapy for ulcerative colitis: The SELECTION
trial. The Lancet. 2021.
https://doi.org/10.1016/S0140-6736(21)00666-82. Ulcerative
colitis. NHS (2021). Available at:
https://www.nhs.uk/conditions/ulcerative-colitis/#:~:text=It’s%20estimated%20around%201%20in,15%20to%2025%20years%20old
[Accessed: October
2021]3. Malodecky NA., et al: Increasing incidence
and prevalence of inflammatory bowel disease with time, based on a
systematic review. Gastroenterology 2012; 142:46-54
ContactsInvestors: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
Marieke VermeerschHead of Corporate Communication+32 479 49 06
03 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, Galapagos’ estimations
regarding the outroll in Europe, including in Great Britain, may be
incorrect 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.
- MHRA_filgo approval_UC_ENG
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