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AbbVie's rheumatoid arthritis drug Rinvoq wins US FDA approval

AbbVie Inc.'s rheumatoid arthritis drug Rinvoq, which the pharma giant said could replace its own blockbuster immunosuppressive drug Humira, has received U.S. Food and Drug Administration approval. It will launch in late August.

Rinvoq is also known as upadacitinib. It will treat adults with moderately to severely active rheumatoid arthritis who cannot take or have had an inadequate response to the commonly used immunosuppressive drug methotrexate, according to AbbVie's Aug. 16 press release.

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.

Rinvoq is a Janus kinase, or JAK, inhibitor that blocks the enzymes associated with driving rheumatoid arthritis. The drug will be administered orally.

Rinvoq is intended to diversify AbbVie's immunology drug portfolio in the face of Humira's looming patent expiration. Humira's impending biosimilar competition has been a source of concern for investors, but AbbVie CEO Richard Gonzalez told analysts during an earnings call that the new drug could overtake Humira's sales numbers.

Rinvoq's approval was supported by a 4,400-patient phase 3 program, in which the drug achieved all primary goals, with about 30% to 36% of participants seeing almost no disease activity and symptoms after being treated with Rinvoq. Rinvoq's benefits were sustained for up to 26 weeks, North Chicago, Ill.-based AbbVie said.

Common side effects reported during the studies included nausea, fever and upper respiratory tract infections such as sinus infections.

Rinvoq is also being reviewed for approval in Europe, Canada and Japan, according to AbbVie.