EUROPEAN MEDICINES AGENCY VALIDATES
MARKETING APPLICATION FOR FILGOTINIB FOR
THE TREATMENT OF ULCERATIVE COLITIS
-- Application Based on Results from Pivotal Phase 2b/3
SELECTION Trial --
Foster City, Calif., & Mechelen,
Belgium, November 2, 2020, 22.01 CET – Gilead Sciences,
Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG)
today announced that the application for a new indication to the
approved license for filgotinib 200 mg, an oral JAK1 preferential
inhibitor, has been validated and is now under evaluation by the
European Medicines Agency (EMA). The proposed indication is for the
treatment of adults 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.
Ulcerative colitis is a long term, chronic
condition which affects more than 2 million people in the European
Union alone. Symptoms tend to present intermittently, and so
patients usually experience flare-ups and periods of remission. The
EMA application is supported by data from the Phase 2b/3 SELECTION
study, which showed a statistically significantly higher proportion
of patients treated with once-daily, oral, filgotinib 200 mg
achieved clinical remission at week 10 and maintained remission at
week 58 compared with placebo. Additionally, a statistically
significantly higher proportion of patients treated with filgotinib
200 mg achieved endoscopic, histologic and six-month,
corticosteroid-free remission at week 58 compared with placebo. The
SELECTION trial results were presented at the virtual United
European Gastroenterology Week (UEGW) 2020 Meeting last month.
“Today’s news from the EMA is a welcome step
forward in our work aiming to improve outcomes for people living
with inflammatory diseases, many of whom struggle with ongoing
symptoms and are in need of new treatment options,” said Mark
Genovese, MD, Senior Vice President, Inflammation, Gilead
Sciences.
“We are very pleased to have achieved this
important milestone with filgotinib, building on its recent
regulatory approvals in rheumatoid arthritis in the EU and Japan,
as we bring this potential new treatment option one step closer for
people living with UC,” said Dr. Walid Abi-Saab, Chief Medical
Officer, Galapagos.
Initiating assessment of the application begins
the formal evaluation process by the EMA’s Committee for Human
Medicinal Products (CHMP). The filing will be reviewed under the
centralized licensing procedure for all 27 member states of the
European Union, as well as Norway, Iceland and Liechtenstein.
Filgotinib is already licensed in the European Union as
Jyseleca® for the treatment of patients 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). The use of filgotinib for UC
is investigational and is not approved anywhere globally.
About the SELECTION Phase 2b/3
TrialThe SELECTION Phase 2b/3 trial is a multi-center,
randomized, double-blind, placebo-controlled trial that
demonstrated sustained efficacy and safety with filgotinib for the
treatment of moderately to severely active UC. The SELECTION
studies tested 100 mg and 200 mg filgotinib versus placebo in
bio-naïve and bio-experienced moderate to severe UC populations,
the bio-experienced populations included more than 50% of UC
patients who had experienced two different mode of action
biologics. The SELECTION trial demonstrated that a statistically
significantly higher proportion of patients treated with filgotinib
200 mg versus placebo achieved clinical remission at week 10 and
maintained remission at week 58. In addition, statistically
significantly more patients achieved six-month corticosteroid-free
remission. Overall, the incidence of adverse events (AEs), serious
AEs and discontinuations due to AEs were similar in the filgotinib
and placebo groups in both the induction and maintenance periods of
the study. Serious infections, herpes zoster, venous thrombosis,
pulmonary embolism and gastrointestinal perforation were similar
across treatment groups.
About FilgotinibFilgotinib (200
mg and 100 mg tablets) is approved and marketed as Jyseleca® in
Europe and Japan for the treatment of adults with moderately to
severely active RA who have responded inadequately or are
intolerant to one or more disease modifying anti-rheumatic drugs
(DMARDs). Jyseleca® may be used as
monotherapy or in combination with methotrexate (MTX). The full
European Summary of Product Characteristics for filgotinib is
available from the EMA at www.ema.europa.eu, and the interview form
from the Japanese Ministry of Health, Labour and Welfare (MHLW) is
available at www.info.pmda.go.jp.
About the Filgotinib
CollaborationGilead and Galapagos NV are collaborative
partners in the global development of filgotinib in RA,
inflammatory bowel disease and other inflammatory indications. The
companies are conducting global studies investigating the potential
role of filgotinib in a variety of diseases, including the Phase 3
DIVERSITY trial in Crohn’s disease.
More information about clinical trials with
filgotinib can be accessed at: www.clinicaltrials.gov.
About Gilead Sciences Gilead
Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in
areas of unmet medical need. The company strives to transform and
simplify care for people with life-threatening illnesses around the
world. Gilead has operations in more than 35 countries worldwide,
with headquarters in Foster City, California. For more information
on Gilead Sciences, please visit the company’s website at
www.gilead.com.
About GalapagosGalapagos NV
discovers and develops 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 biopharmaceutical company focused on the
discovery, development and commercialization of innovative
medicines. More information at www.glpg.com.
Gilead Forward-Looking
StatementThis press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks, uncertainties and
other factors. There is also the possibility of unfavorable results
from ongoing and additional clinical trials involving filgotinib,
including the SELECTION long-term extension trial and the DIVERSITY
trial. Further, it is possible that the parties may make a
strategic decision to discontinue development of filgotinib for the
treatment of ulcerative colitis or other indications, and as a
result, filgotinib may never be successfully commercialized for the
treatment of ulcerative colitis or other indications. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Form 10-Q for the quarter ended June 30, 2020,
as filed with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
Galapagos Forward-Looking
StatementThis 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 for ulcerative colitis or other indications due to
safety, efficacy or other reasons, the timing or likelihood of
regulatory authorities’ approval of marketing authorization for
filgotinib for ulcerative colitis or other indications, such
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®, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc. or its related companies.
Contacts Galapagos |
|
Investors: |
Media: |
Elizabeth Goodwin |
Carmen Vroonen |
VP IR |
Global Head of Communications & Public Affairs |
+1 781 460 1784 |
+32 473 824 874 |
|
|
Sofie Van Gijsel |
Anna Gibbins |
Senior Director IR |
Senior Communications Director – Therapeutic Areas |
+32 485 19 14 15 |
+44 (0) 7717 801900 |
ir@glpg.com |
communications@glpg.com |
|
|
Contacts Gilead |
|
Investors: |
Media: |
Douglas Maffei, PhD |
Jennifer Wilson, Media - Europa |
+1 650 522-2739 |
+44 7920 266-582 |
|
|
|
Marian Cutler, Media - US |
|
+1 (973) 517-0519 |
Contacten Galapagos
Investeerders: Media:
Elizabeth Goodwin Carmen Vroonen VP
IR Global Head of Communications & Public Affairs
+1 781 460 1784 +32 473 824 874 Sofie Van
Gijsel Senior Director IR +32 485 19 14
15 ir@glpg.com
Contacten Gilead
Investeerders: Media:
Douglas Maffei, PhD Jennifer Wilson, Media - Europa +1 650
522-2739 +44 7920 266-582 Marian
Cutler, Media - US +1 (973) 517-0519
- EUROPEAN MEDICINES AGENCY VALIDATES MARKETING APPLICATION FOR
FILGOTINIB FOR THE TREATMENT OF ULCERATIVE COLITIS
Grafico Azioni Galapagos (EU:GLPG)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Galapagos (EU:GLPG)
Storico
Da Apr 2023 a Apr 2024