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AbbVie seeks approval of upadacitinib in U.S., Europe for psoriatic arthritis


AbbVie announces they have filed applications with the U.S. FDA and EMA for the approval of the JAK inhibitor upadacitinib for the treatment of adult active psoriatic arthritis.

A new treatment may be available in the near future for adult patients with active psoriatic arthritis (PsA) in the United States and Europe. AbbVie announced June 1 that it has filed applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the approval of upadacitinib (RINVOQ).

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Upadacitinib 15 mg is a reversible and selective JAK inhibitor that was initially approved in the United States in August 2019 for the treatment of moderate-to-severe rheumatoid arthritis in adult patients who experience an insufficient or no response to methotrexate and was subsequently approved in Europe in December 2019.

The application submissions come after positive results from two phase 3 studies that investigated the drug in over 2,000 patients with active PsA. Upadacitinib met the primary endpoint of ACR20 response at week 12 compared to placebo in both studies and succeeded non-inferiority compared to adalimumab (Humira, AbbVie) in ACR20 response at week 12, according to a press release.

Additionally, results showed that a greater proportion of patients receiving upadacitinib achieved minimal disease activity. Patients receiving the drug also experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75). The safety profile was consistent with previous phase 3 trials investigating upadacitinib for rheumatoid arthritis.

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"Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness," says Michael Severino, M.D., vice chairman and president of AbbVie. "We look forward to working with regulatory authorities and hope to bring RINVOQ to people living with this debilitating disease as quickly as possible."

Upadacitinib is currently being investigated in ongoing phase 3 trials as a treatment for a variety of indications including Crohn’s disease, rheumatoid arthritis, atopic dermatitis, PsA, axial spondylarthritis, giant cell arteritis and ulcerative colitis.


1. AbbVie. (2020, June 1). AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis [Press release]. Retrieved June 2, 2020, from https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-rinvoq-upadacitinib-for-treatment-adults-with-active-psoriatic-arthritis.htm

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