19 August 2019 - - The Marketing Authorization Application for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis has been validated and is now under evaluation by the European Medicines Agency, US-based Gilead Sciences, Inc. (NASDAQ: GILD) and Belgium-based Galapagos NV (Euronext and NASDAQ: GLPG) said.

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.

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 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.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.

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.

Galapagos (Euronext and NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising 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 global biopharmaceutical company focused on the discovery, development and commercialisation of innovative medicines.