AbbVie, a research-based global biopharmaceutical company, announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis.
“Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness,” said Michael Severino, M.D., vice chairman and president, 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.”
The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis. In both studies, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo. RINVOQ 15 mg also achieved non-inferiority versus adalimumab in terms of ACR20 response at week 12. Patients receiving RINVOQ also experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a greater proportion achieved minimal disease activity. Overall, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.