Rinvoq receives FDA approval to treat active psoriatic arthritis.- AbbVie

"The efficacy of Rinvoq in relieving the many manifestations of psoriatic arthritis is well-characterized in two large, long term clinical studies," said Michael Severino, M.D., vice chairman and president, AbbVie. "This new approval underscores our mission to deliver a portfolio of therapies that can help more people with rheumatic diseases achieve disease control." The FDA approval is supported by data from two pivotal Phase III trials, SELECT-PsA 1 and SELECT-PsA 2, which assessed the efficacy, safety and tolerability of Rinvoq in patients with PsA. In both studies, the safety profile in patients with active PsA treated with Rinvoq 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis.

"Many adults still struggle to find a treatment option that helps them lower their disease activity," said Iain McInnes, professor of medicine and Versus Arthritis professor of rheumatology at University of Glasgow, U.K., and lead investigator of the SELECT-PsA 1 trial. "With this FDA approval, Rinvoq has the potential to help more people find meaningful relief from the signs and symptoms of psoriatic arthritis that they see and feel and to help reach their treatment goals."

Across SELECT-PsA 1 and SELECT-PsA 2 Phase III clinical trials, Rinvoq met its primary endpoint of ACR20 at week 12 with patients taking Rinvoq 15 mg achieving significantly higher ACR20 responses (71% and 57%, respectively) versus placebo (36% and 24%, respectively).