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EMA to review Gilead's application for rheumatoid arthritis drug

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EMA to review Gilead's application for rheumatoid arthritis drug

The European Medicines Agency approved for review Gilead Sciences Inc.'s marketing application for filgotinib to treat rheumatoid arthritis in adults.

Rheumatoid arthritis is an autoimmune disorder that occurs when the immune system mistakenly attacks the body's tissues, primarily causing pain, swelling and stiffness in the joints.

Filgotinib, which inhibits an enzyme called Janus kinase 1, or JAK1, is yet to be approved by any regulatory authority.

Gilead's application for filgotinib was backed by 24-week data from late-stage studies named Finch, which showed that once-daily treatment with the experimental drug improved symptoms in rheumatoid arthritis patients.

The U.S. drugmaker and Belgium's Galapagos NV are collaborating on filgotinib under a deal the companies entered in December 2015.

Gilead also plans to submit an application seeking U.S. Food and Drug Administration approval for filgotinib as a treatment for rheumatoid arthritis before the end of 2019.