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AbbVie's rheumatoid arthritis drug Rinvoq wins EU approval

The European Commission approved North Chicago, Ill.-based AbbVie Inc.'s Rinvoq for the treatment of certain adult rheumatoid arthritis patients.

The regulator approved Rinvoq, or upadacitinib, to treat adult patients with moderate to severe active rheumatoid arthritis who cannot take or have responded inadequately to one or more disease-modifying anti-rheumatic drugs.

Rheumatoid arthritis is an autoimmune disease affecting about 23.7 million people worldwide. It occurs when the immune system mistakenly attacks its own tissue, causing pain, swelling and bone erosion.

The approval was supported by a 4,400-patient phase 3 Select program, in which the drug achieved all primary goals, with a higher percentage of patients experiencing almost no symptoms and disease activity after being treated with the drug.

Earlier in August, the U.S. Food and Drug Administration approved Rinvoq for the same indication.