Galapagos announces CHMP adoption of PRAC’s recommendation for
Jyseleca® following extensive safety review of all JAK inhibitors
- Supportive outcome for Jyseleca as treatment option with a
positive benefit/risk profile after review of safety data of all
JAK inhibitors approved in Europe for treatment of inflammatory
conditions
- This follows the recommended harmonization of EU labels for all
JAK inhibitors by Pharmacovigilance Risk Assessment Committee
(PRAC)
- For patients aged ≥65 years, current or long-time past smokers
and patients with a history of atherosclerotic cardiovascular (CV)
disease or other CV and malignancy risk factors, risk minimization
measures have been adopted
Mechelen,
Belgium; 11
November 2022, 13.15 CET;
Galapagos NV (Euronext & NASDAQ:
GLPG) today announced that
the Committee for Medicinal Products for Human Use
(CHMP), the scientific committee of
the European Medicines
Agency
(EMA), has adopted
PRAC’s recommendation to add measures to
minimise risk of serious side effects
with JAK inhibitors for chronic
inflammatory disorders.
“JAK inhibitors are an important treatment
option for patients based on individual benefit/risk and we see
this outcome as a positive evolution in supporting the best
use of the JAK inhibitor class” said Dr. Walid Abi-Saab, Chief
Medical Officer of Galapagos. “Jyseleca is the only 2nd generation
JAK inhibitor with JAK1 preferential inhibition of both approved
doses, as well as the possibility of treating with the lowest
effective dose in both RA and UC. We are very pleased with today’s
outcome as we continue our mission to improve lives of people
living with inflammatory diseases.”
The product labels of all JAK inhibitors will be
updated to include a precautionary approach for patients aged 65
years or above, those at increased risk of major cardiovascular
problems (such as heart attack or stroke), those who smoke or have
done so for a long time in the past and those at increased risk of
cancer. For those at-risk patients, the recommendation is that JAK
inhibitors, including Jyseleca, should be used only if no suitable
treatment alternatives are available. The CHMP followed PRAC’s
recommendation that JAK inhibitors should be used with caution in
patients with risk factors for blood clots in the lungs and in deep
veins (venous thromboembolism, VTE) other than those listed
above.
Following today’s CHMP opinion, filgotinib 200mg
once daily remains the recommended dose for the treatment of
patients with RA. For patients with UC, filgotinib 200mg once daily
remains the recommended dose for induction and maintenance therapy.
Dose adjustments are recommended for patients aged 65 years or
above and/or at risk of major adverse cardiac events (MACE), VTE or
malignancy, namely 100mg once daily dose in patients with RA, which
can be escalated to 200mg in case of insufficient disease control.
For at-risk patients with UC, the initiation dose remains
unchanged, but a maintenance dose of 100mg should be considered. In
case of a flare of disease, the dose should be escalated to 200mg
once daily. For long-term treatment in patients with above risk
factors, the lowest effective dose should be used.
“The recommendation by the PRAC reflects the
concerns raised by the substance class mainly in older patients
with rheumatoid arthritis,” said Dr. Stefan Schreiber, Professor of
Medicine and Gastroenterology at the Christian-Albrechts-University
in Kiel, Director of the Clinic for Internal Medicine at the
University Hospital Schleswig-Holstein and Leader of Translational
Inflammation Research Group in the Kiel University. “It is
comforting to see that we still have the option for a
benefit-oriented use of filgotinib in ulcerative colitis to provide
fast anti-inflammatory efficacy to the main patient group.”
Professor Lars Erik Vølund Kristensen, Professor
and CSO at the Parker Institute, University of Copenhagen and
Associate Professor at Lund University, Sweden, said, "It is
reassuring to see that we can still use JAK inhibitors to help a
large proportion of our arthritis patients to obtain fast acting
and effective anti-inflammatory treatment. I find that PRAC's
recommendation harmonizes well with the concerns raised by the Oral
Surveillance study, which included older rheumatoid arthritis
patients with cardiovascular risk factors."
The CHMP opinion follows the recommendation of
the PRAC which carried out a safety review (Article 20 procedure)
of all EU-approved JAK inhibitors, including filgotinib, following
the Oral Surveillance data on tofacitinib and recent data from a
retrospective observational study with baricitinib. The Article 20
procedure is a specific pharmacovigilance (PV) procedure which
allowed the EMA to investigate the quality, efficacy, and safety
issues for one or more centrally approved products – in this case a
safety review on MACE, VTE, serious infections, malignancies, and
mortality for the JAK inhibitors authorised in inflammatory
diseases.
The European Commission decision is expected by
January 2023, approximately 60 days after today’s CHMP opinion,
following which the language in the ‘special warnings and
precautions for use’ and the ‘posology’ sections of the Summary of
Product Characteristics (SmPC) will be updated.
About filgotinibFilgotinib is
marketed as Jyseleca in the European Union (incl. Norway), Great
Britain, and Japan for the treatment of adults with moderately to
severely active rheumatoid arthritis (RA) who have responded
inadequately or are intolerant to one or more disease modifying
anti-rheumatic drugs (DMARDs). Filgotinib is also marketed as
Jyseleca in the European Union (incl. Norway), Great Britain, and
Japan 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. Jyseleca (filgotinib)
100mg and 200mg are registered in the above- mentioned territories.
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.
The European Summary of Product Characteristics
for filgotinib, which includes contraindications and special
warnings and precautions, is available at www.ema.europa.eu. 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, respectively. The
interview form from the Japanese Ministry of Health, Labour and
Welfare is available at www.info.pmda.go.jp.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies. Except for
filgotinib’s approval as Jyseleca for the treatment of moderately
to severely RA and UC by the relevant regulatory authorities in the
European Union, Great Britain, and Japan, our drug candidates are
investigational; their efficacy and safety have not been fully
evaluated by any regulatory authority.
About Rheumatoid
ArthritisRheumatoid arthritis (RA) is an autoimmune
inflammatory disease that primarily causes pain, stiffness and
swelling in the joints. RA often follows a painful, progressively
debilitating course, depriving patients of the ability to continue
their daily lives and leading to physical disability. Despite
current treatments, RA continues to pose a substantial burden to
people living with the disease, comprised of the daily health
issues directly related to their RA, such as pain, and the
complications of managing comorbid conditions.1,2,3
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 2.5 - 3 million people4 are
affected by IBD, which includes UC and Crohn’s disease (CD). UC is
a chronic inflammatory condition characterized by periods of flare
ups followed by remission. In addition to the physical impact from
flare ups, there is also a 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 GalapagosGalapagos is a
fully integrated biotechnology company focused on discovering,
developing, and commercializing innovative medicines. We are
committed to improving patients’ lives worldwide by targeting
diseases with high unmet needs. Our R&D capabilities cover
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to Phase 4
programs in immunology, oncology and other indications. Our first
medicine for rheumatoid arthritis and ulcerative colitis is
available in the European Union, Norway, Great Britain, and Japan.
For additional information, please visit www.glpg.com or follow us
on LinkedIn or Twitter.
Contact
Investors:Sofie Van GijselHead of Investor
Relations+1 781 296 1143
Sandra CauwenberghsDirector Investor Relations+32 495 58 46
63ir@glpg.com
Media:Marieke VermeerschHead of Corporate
Communication+32 479 490 603media@glpg.com
Forward Looking Statements
This press release includes forward-looking
statements, all of which involve certain risks and uncertainties.
These statements are often, but are not always, made through the
use of words or phrases such as “possibility,” “will,” “continue,”
“expect,” “should,” and “recommendation,” as well as similar
expressions. Forward-looking statements contained in this release
include, but are not limited to, statements regarding the PRAC
recommendation for filgotinib, statements regarding the expected
timing of the EC’s decision, statements related to Galapagos’ plans
and strategy with respect to Jyseleca, statements relating to
interactions with regulatory authorities, the timing or likelihood
of additional regulatory authorities’ approval of marketing
authorization for filgotinib for RA, UC or any other indication for
filgotinib in Europe, Great Britain, or Japan,. Any forward-looking
statements in this release are based on Galapagos management’s
current expectations and beliefs and are not guarantees of future
performance. Forward-looking statements involve known and unknown
risks, uncertainties and other factors which might cause Galapagos’
actual results, performance or achievements to be materially
different from any historic or future results, performance or
achievements expressed or implied by such forward-looking
statements. These risks, uncertainties and other factors include,
without limitation, the risk that ongoing and future clinical
studies with filgotinib may not be completed in the
currently envisaged timelines or at all, the inherent risks
associated with clinical trial and product development activities,
including the filgotinib clinical program and the FILOSOPHY and
FINCH 4 LTE study, the inherent risks and uncertainties
associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements
(including that data from the ongoing and planned clinical research
programs, including but not limited to the data from the ongoing
FILOSOPHY or FINCH 4 LTE study, may not support registration or
further development of filgotinib due to safety, efficacy
or other reasons), the risks related to continued regulatory
review of filgotinib following approval by relevant regulatory
authorities, including EMA’s safety review of JAK inhibitors used
to treat certain inflammatory disorders, the risks
that regulatory authorities may require additional
post-approval trials of filgotinib or any other product candidates
that are approved in the future, Galapagos' reliance on
collaborations with third parties (including our collaboration
partner for filgotinib, Gilead) and that Galapagos’
estimations regarding its filgotinib development program
and regarding the commercial potential of filgotinib may be
incorrect, 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, and risks related to
the ongoing COVID-19 pandemic, as well as those risks and
uncertainties identified in our most recent Annual Report on Form
20-F filed with the U.S. Securities and Exchange Commission
(SEC), as supplemented and/or modified by any other filings and
reports that we have made or will make with the SEC in the future.
Given these risks and uncertainties, the reader is advised not to
place any undue reliance on such forward-looking statements. In
addition, even if Galapagos’ results, performance or achievements
are consistent with such forward-looking statements, they may not
be predictive of results, performance or achievements in future
periods. These forward-looking statements speak only as of the date
of publication of this release. Galapagos expressly disclaims any
obligation to update any such forward-looking statements in this
release unless required by law or regulation.
1 Taylor PC, Moore A, Vasilescu R, Alvir J, Tarallo M. A
structured literature review of the burden of illness and unmet
needs in patients with rheumatoid arthritis: a current perspective.
Rheumatology International. 2016;36(5):685-95.2 Radner H, et al.
Comorbidity affects all domains of physical function and quality of
life in patients with rheumatoid arthritis Rheumatology 2011
Feb;50(2):381-8.3 An J, et al. Prevalence of comorbidities and
their associations with health-related quality of life and
healthcare expenditures in patients with rheumatoid arthritis Clin
Rheumatol. 2019; 38(10):2717-2726.4 Burisch J. et al. Journal of
Crohn’s and Colitis (2013); 7:322-337.
- Galapagos announces CHMP adoption of PRAC’s recommendation for
Jyseleca® following extensive safety review of all JAK
inhibitors
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