AbbVie is seeking to expand the scope of Rinvoq (upadacitinib) in the US and Europe to include the treatment of adults with active psoriatic arthritis.
The drugmaker has confirmed marketing application submissions for the new indication to both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), which are based on data from two Phase III studies including more than 2,000 patients.
In both studies, Rinvoq met the primary endpoint of ACR20 response at week 12 versus placebo, and 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, the firm noted.
“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, 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.”
Rinvoq is a selective and reversible JAK inhibitor being studied in several immune-mediated inflammatory diseases. The drug was approved last year to treat adults with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.