European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Ulcerative Colitis

Gilead Sciences and Galapagos 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.

Mark Genovese, MD, Senior Vice President, Inflammation, Gilead Sciences Commented “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.”

Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos Commented “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.”

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 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 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 

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.

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