The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
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AbbVie’s Rinvoq won approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or demonstrated an intolerance to one or more tumor necrosis factor (TNF) blockers.
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2. The late-stage studies assessed Rinvoq, a JAK inhibitor, in psoriatic arthritis patients.
In both studies, a 15mg dose of Rinvoq demonstrated safety and efficacy that has been seen in other studies that led to the approval of the drug, including in rheumatoid arthritis patients. Rinvoq met the primary endpoint of ACR20 response at week 12 compared to placebo in the patient population. Compared to placebo, Rinvoq demonstrated a statistically significant higher ACRO20 response, 71% to 36% in the SELECT-PsA 1 study and 57% to 24% in SELECT-PsA 2.
Iain McInnes, professor of medicine and Versus Arthritis professor of rheumatology at University of Glasgow in Scotland, and lead investigator of the SELECT-PsA 1 trial, noted that many adults with psoriatic arthritis continue to struggle to find an adequate response to popular TNF blockers, such as AbbVie’s blockbuster Humira or Amgen’s Enbrel.
“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.”
Michael Severino, vice chairman and president of AbbVie, said the efficacy of Rinvoq in multiple manifestations of psoriatic arthritis was well-characterized in these two studies. He said the newest approval for Rinvoq “underscores” AbbVie’s mission to deliver therapies that can help more people with rheumatic diseases achieve disease control.
Rinvoq was first approved in 2019 as a treatment for rheumatoid arthritis. It has also acquired regulatory approval for the treatment of active psoriatic arthritis and active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.
The latest approval for Rinvoq comes weeks after the FDA placed new safety warnings on JAK inhibitors. As BioSpace previously reported, the FDA decision came after reviewing a post-marketing study on Pfizer’s Xeljanz (tofacitinib), another JAK inhibitor. Data from that study revealed a higher rate of major adverse cardiac events (MACE), malignancy, mortality and thrombosis in patients who received Xeljanz.
Following the review, the FDA issued a decree to update the warning labels of JAK inhibitors to include the latest safety issues. Blood clots and lymphoma are already listed as boxed warnings for this class of drugs.
In addition to Rinvoq and Xeljanz, there is one other FDA-approved JAK inhibitor, Eli Lilly’s Olumiant.
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