Gilead Sciences submits new drug application in Japan for filgotinib for the treatment of ulcerative colitis with an inadequa...
April 23 2021 - 12:01AM
Application is based on Phase 2b/3 SELECTION study data with
patients with moderately to severely active ulcerative colitis
Mechelen,
Belgium; 23
April 2021;
06.01 CET;
– Galapagos NV (Euronext & Nasdaq:
GLPG) today report that
their collaboration partner Gilead
Sciences K.K.
(“Gilead”)
and Eisai Co., Ltd. (“Eisai”)
today announced that Gilead submitted an
application to Japan’s Pharmaceuticals and Medical Devices Agency
(PMDA) for approval of filgotinib
for an additional indication to treat patients with
moderately to severely active ulcerative colitis
(UC). Filgotinib
is a new oral Janus kinase (JAK) inhibitor approved in
Japan in September 2020 for the treatment of rheumatoid
arthritis.
This latest regulatory submission is based on data from the
randomized, double-blind, placebo-controlled Phase 2b/3 SELECTION
study evaluating the efficacy and safety of filgotinib for the
induction and maintenance of remission in 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. This study showed a
statistically significant higher proportion of patients treated
with filgotinib 200mg once daily achieved clinical remission at
week 10 and maintained remission at week 58 compared with placebo.
No new safety risks were identified.
Ulcerative colitis is a chronic disease
characterized by inflammation of the lining of the mucosa of the
colon and rectum. The prevalence of ulcerative colitis has been
increasing in recent years, and it has a significant impact on the
quality of life of more than 2 million people around the world.
Even with treatment, defecation urgency, incontinence, recurrent
bloody diarrhea, frequent bowel movements, abdominal pain, insomnia
and fatigue are common. Ulcerative colitis is one of the
intractable diseases1 designated by the Ministry of Health,
Labour and Welfare in Japan. According to a nationwide survey, the
estimated number of patients with ulcerative colitis in Japan in
2014 was 219,685. The annual prevalence rate per 100,000 was 172.9
(192.3 men, 154.5 women).2
About
filgotinibFilgotinib is approved
and marketed as Jyseleca (200mg and 100mg tablets) in the Europe
Union, 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 may be used as
monotherapy or in combination with methotrexate (MTX). This
definition from 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 is available at www.medicines.org.uk/emc.
Applications have been submitted to the EMA, the MHRA and the PMDA
for the treatment of adults 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 and are currently under review. Filgotinib is
not approved in any other countries.
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 and Japan and a global
Phase 3 program is ongoing in Crohn’s Disease. More information
about clinical trials can be accessed at
www.clinicaltrials.gov.
About Galapagos Galapagos NV
discovers, develops and commercializes 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 biotech company focused on the discovery,
development and commercialization of innovative medicines. More
information at www.glpg.com.
Contacts
Investors:Elizabeth GoodwinVP
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 Director Therapeutic Areas Communications+44
7717 801900communications@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, 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, statements
relating to interactions with the regulatory authorities,
Galapagos’ strategic R&D ambitions and potential changes of
such ambitions, 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 implementing the
amendment of our arrangement with Gilead for the commercialization
and development of Jyseleca (filgotinib), the uncertainties
relating to the impact of the COVID-19 pandemic, 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.
1Japan promotes research related to intractable diseases and
financially supports patients with these diseases. Intractable
diseases are designated as those that fulfill the following
criteria: (1) rarity (affecting less than 0.1% of the population in
Japan), (2) unknown etiology, (3) lack of effective treatment, (4)
necessity of long-term treatment, and (5) existence of objective
diagnostic criteria and not necessarily equal to rare diseases in
other countries. Neurol Med Chir (Tokyo). 2017 Jan; 57(1):
1–7. Published online 2016 Sep
21. doi: 10.2176/nmc.st.2016-0135
2Murakami Y, Nishiwaki Y, Oba MS, Asakura K, Ohfuji S, Fukushima
W, et al. Estimated prevalence of ulcerative colitis and Crohn’s
disease in Japan in 2014: an analysis of a nationwide survey. J
Gastroenterol 2019;54 (12):1070-7
- Gilead Sciences submits new drug application in Japan for
filgotinib for the treatment of ulcerative colitis with an
inadequate response to conventional therapies
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