European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Ulcerative Colitis - Seite 2
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.
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Filgotinib (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 Collaboration
Gilead 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.
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