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AbbVie has submitted a marketing application to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its new adaptation of the JAK inhibitor Rinvoq (upadacitinib) for the treatment of adult patients with active psoriasis arthritis.
this is based on data from two phase III studies involving more than 2,000 patients.
In both studies, Rinvoq reached the primary endpoint of the ACR20 response in week 12 compared to placebo, and achieved non-adverse effects at week 12 against anti-tumor necrotologist adalimumab.
the company noted that physical function (HAQ-DI) and skin symptoms (PASI 75) in patients treated with Rinvoq had also improved.
Severino, vice chairman and president of
AbbVie, said: "Psoriasis arthritis is a complex heterogeneity disorder with symptoms in multiple tissues, including joints and skin, leading to pain, fatigue and stiffness.
"We look forward to working with regulators to bring Rinvoq to this category of patients as soon as possible."
" Rinvoq is a selective and reversible JAK inhibitor that is being studied in a variety of immunomedulation inflammatory diseases.
the drug was approved last year to treat adult patients with moderate to severe active rheumatoid arthritis who have a poor or insatiable response to one or more disease-relieving anti-rheumatoid drugs.
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