Correction: Jyseleca® (filgotinib) approved in Japan for rheumatoid arthritis
September 25 2020 - 2:13AM
Filgotinib demonstrates durable efficacy and consistent safety
profile through 52 weeks in clinical trials
Mechelen, Belgium; 25 September 2020,
08.00 CET – Galapagos NV (Euronext & NASDAQ: GLPG) reports
that Gilead Sciences, Inc. (Nasdaq: GILD) and
Eisai Co., Ltd. (Tokyo, Japan) today announced that the Japanese
Ministry of Health, Labour and Welfare (MHLW) has granted Gilead
K.K. (Tokyo, Japan) regulatory approval of
Jyseleca® (filgotinib 200 mg and
100 mg tablets), a once-daily, oral, JAK1 inhibitor for the
treatment of rheumatoid arthritis (RA) in patients who have had an
inadequate response to conventional therapies, including the
prevention of structural joint damage.
Gilead Japan will hold the marketing
authorization of Jyseleca in Japan and will be responsible for
product supply of Jyseleca in Japan, while Eisai will be
responsible for product distribution of Jyseleca in Japan in RA.
The companies will jointly commercialize the medicine to make it
available to physicians and patients across Japan.
For more information, please see Gilead’s full
press release on www.gilead.com.
Gilead is developing Jyseleca in collaboration
with Galapagos. The two companies are conducting global studies
investigating the potential role of Jyseleca in a variety of
diseases, including the previously reported Phase 3 SELECTION trial
in ulcerative colitis.
About GalapagosGalapagos
discovers and develops small molecule medicines with novel modes of
action, three of which show promising patient results and are
currently in late-stage development in multiple diseases. The
company’s pipeline comprises Phase 3 through to discovery programs
in inflammation, fibrosis, osteoarthritis and other indications.
Galapagos’ 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.
Galapagos 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 statements
This 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 due to safety, efficacy or other reasons, the timing or
likelihood of additional regulatory authorities approval of
marketing authorization for filgotinib, such additional regulatory
authorities requiring additional studies, Galapagos’ reliance on
collaborations with third parties, including the collaboration with
Gilead for filgotinib, the uncertainty regarding estimates of the
commercial potential of filgotinib, as well as those risks and
uncertainties identified in our Annual Report on Form 20-F for the
year ended 31 December 2019 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.
- Jyseleca® (filgotinib) approved in Japan for rheumatoid
arthritis
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