FDA Delays PDUFA Date for Upadacitinib for Psoriatic Arthritis, Ankylosing Spondylitis

The US Food and Drug Administration (FDA) will not rule on the supplemental New Drug Application (sNDA) for upadacitinib (RINVOQ) for the for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis.

While there was a Prescription Drug User Fee Act (PDUFA) action date set for June 25, AbbVie announced the FDA delayed the PDUFA date.

"RINVOQ has demonstrated strong efficacy data, a safety profile that is well characterized from large long-term studies and a favorable benefit-risk profile," said Michael Severino, MD, vice chairman and president, AbbVie, in a statement. "We remain committed to working with the FDA to bring RINVOQ to patients living with psoriatic arthritis, ankylosing spondylitis and other immune-mediated diseases."

The Drug

Upadacitnib is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. The FDA previously approved the treatment for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Trials

In data presented during the EULAR 2021 Virtual Congress, upadacitinib effectively treated patients with psoriatic arthritis and axial involvement, a group that is historically more likely to have higher disease burden and more quality-of-life impairments than patients without axial involvement.

There are currently ongoing phase 3 trials testing the safety and efficacy of upadacitinib in patients with rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.