Jyseleca® approved in Japan for ulcerative colitis
March 28 2022 - 2:01AM
Jyseleca® approved in Japan for ulcerative colitis
Approval of
additional indication based on Phase 2b/3
SELECTION study in patients with
moderate-to-severe ulcerative colitis
Mechelen, Belgium; 28
March 2022,
08.01
CET; Galapagos NV (Euronext & NASDAQ:
GLPG) reports that Gilead Sciences K.K. (Tokyo,
Japan), Eisai Co., Ltd. (Tokyo, Japan) and EA Pharma
Co., Ltd. (Tokyo, Japan) today
announced the approval by the
Japanese Ministry of Health, Labour
and Welfare (MHLW), of a
second indication for Jyseleca
(filgotinib), a once-daily, oral,
JAK1 preferential inhibitor, for
the treatment of patients with moderate-to-severe active ulcerative
colitis (UC).
The approval of this second indication for
Jyseleca in Japan is based on data from the randomized,
double-blind, placebo-controlled phase 2b/3 SELECTION study. This
study evaluated the efficacy and safety of Jyseleca for induction
and maintenance of remission in patients with moderately to
severely active ulcerative colitis who had an inadequate response
with, lost response to, or were intolerant to either conventional
therapy or a biologic agent. The study showed that Jyseleca 200mg
was well-tolerated and efficacious as induction and maintenance
therapy with no new safety findings reported. Jyseleca was approved
in Japan in September 2020 for the treatment of rheumatoid
arthritis (RA), including the prevention of structural joint
damage, in patients who had inadequate response to conventional
therapies.
Gilead Japan will hold the marketing
authorization of Jyseleca in Japan and will be responsible for
product supply. Eisai will be responsible for product distribution,
and together with EA Pharma, its subsidiary focused on
gastrointestinal diseases, will jointly commercialize the medicine
to make it available to physicians and patients across the
country.
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, Great Britain and Japan 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 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 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
GalapagosGalapagos 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.
ContactInvestors: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+32 479 490 603
Anna GibbinsSenior Director Therapeutic Area Communications+44
7717 801900
media@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. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. When used in this press release, the
words “ongoing,” “may,” “who,” “will,” “plan” and similar
expressions are intended to identify forward-looking statements.
These statements include, but are not limited to: statements
regarding the global R&D collaboration with Gilead and product
supply of filgotinib in moderate-to-severe UC in Japan; statements
regarding product distribution by Eisai of filgotinib in
moderate-to-severe UC in Japan; statements regarding joint
commercialization in Japan of filgotinib in moderate-to-severe UC
by Eisai and its subsidiary EA Pharma; and other statements and
expectations regarding commercial sales for filgotinib and rollout
in Europe. These risks, uncertainties and other factors include,
without limitation, risks related to continued regulatory review of
filgotinib following approval by relevant regulatory authorities,
including the EMA’s planned safety review of JAK inhibitors used to
treat certain inflammatory disorders, and the risk that the EMA’s
planned safety review may negatively impact acceptance of
filgotinib more widely by patients, the medical community, and
healthcare payors, as well as the risk that the MHLW could
undertake a similar review; the risk that regulatory authorities
may require additional post-approval trials of filgotinib or any
other product candidates that are approved in the future; risks
related to Galapagos’ reliance on third parties, and risks related
to the ongoing COVID-19 pandemic. For a discussion of other risks
and uncertainties and other important factors, any of which could
cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled “Risk Factors”
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. All information in this press
release is as of the date of the release, and Galapagos undertakes
no duty to update this information unless required by law or
regulation.
.
- Gilead Japan Jyseleca UC approval_250322_FINAL
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