AbbVie files for added Rinvoq indications with FDA and EMA

Applications for a new indication have been submitted to the US Food and Drug Administration and European Medicines Agency for Rinvoq (upadacitinib) 15mg, once daily, a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis, by US biopharma major AbbVie (NYSE: ABBV), whose shares closed down 1.6% at $91.28 following the announcement yesterday.

"Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness," said Dr Michael Severino, vice chairman and president, AbbVie, adding: "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 III 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.