-- Application Based on Results from Pivotal Phase 2b/3 SELECTION Trial --
Ulcerative colitis is a long term, chronic condition which affects more than 2 million people in the
“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
“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
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
About the SELECTION Phase 2b/3 Trial
The 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 Filgotinib
Filgotinib (200 mg and 100 mg tablets) is approved and marketed as Jyseleca® in
About the Filgotinib Collaboration
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
About Galapagos
Gilead Forward-Looking Statement
This 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
Galapagos Forward-Looking Statement
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 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
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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 |
Senior Director IR | |
+32 485 19 14 15 | +44 (0) 7717 801900 |
ir@glpg.com | communications@glpg.com |
Contacts Gilead | |
Investors: | Media: |
Jennifer Wilson, Media - Europa | |
+1 650 522-2739 | +44 7920 266-582 |
+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
Attachment
- EUROPEAN MEDICINES AGENCY VALIDATES MARKETING APPLICATION FOR FILGOTINIB FOR THE TREATMENT OF ULCERATIVE COLITIS
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