European Medicines Agency validates marketing application for Filgotinib for the treatment of rheumatoid arthritis

Wednesday, August 28, 2019

Gilead Sciences, Inc. and Galapagos NVannounced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and is now under evaluation by the European Medicines Agency (EMA).

“We are excited about the validation of this application which is an important milestone in our ongoing work to improve the lives of people living with rheumatoid arthritis and other inflammatory conditions,” said John Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory Diseases, Gilead Sciences.

The MAA for filgotinib is supported by 24-week data from the Phase 3 FINCH clinical trials in which once-daily treatment with filgotinib achieved improvements in clinical signs and symptoms, achievement of low disease activity and remission, and inhibition of structural damage for different sub-populations of patients living with RA. Across the FINCH program, safety data were consistent with previously reported results.

“We are very happy with the validation of the filgotinib MAA by the EMA, as this represents the latest step forward in our partnership with Gilead to bring filgotinib as a new treatment option to RA patients across Europe,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.

The filgotinib filing will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, as well as Norway, Iceland, and Liechtenstein. In early July, Gilead announced plans to submit a New Drug Application (NDA) for filgotinib for the treatment of RA in the United States before the end of the year.

Filgotinib is an investigational agent and is not approved anywhere globally. Its efficacy and safety have not been established by any regulatory authorities.

About the Galapagos – Gilead Collaboration

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications.  The FINCH studies are among several clinical trials of filgotinib in inflammatory diseases, including the EQUATOR Phase 2 study in psoriatic arthritis, the TORTUGA Phase 2 study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.

About Galapagos

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show patient results and are currently in late-stage development in multiple diseases. Its 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.

   
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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