FDA Fails to Provide Approval Decision on Upadacitinib for PsA

The FDA has informed AbbVie that the regulatory agency will not meet the June 25 Prescription Drug User Fee Act (PDUFA) action date for upadacitinib’s supplemental New Drug Application (sNDA). Upadacitinib is a treatment for adults with active psoriatic arthritis (PsA) (Rinvoq; AbbVie).¹

Upadacitinib is an oral, reversible, and selective JAK inhibitor that was initially approved in the U.S. in August 2019 for the treatment of moderate to severe rheumatoid arthritis in adult patients who experience an insufficient or no response to methotrexate and was subsequently approved in Europe in December 2019.²

The FDA attributes the PDUFA delay to its ongoing review of Pfizer's post-marketing study (ORAL Surveillance) evaluating tofacitinib in patients with rheumatoid arthritis. There is currently no update on upadacitinib’s expected decision date.

AbbVie initially sought approval from both the FDA and European Medicines Agency (EMA) for upadacitinib in June 2020.³ 

"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. "We remain committed to working with the FDA to bring Rinvoq to patients living with psoriatic arthritis, ankylosing spondylitis and other immune-mediated diseases."

References:

1. AbbVie provides update regarding rinvoq (upadacitinib) in psoriatic arthritis and ankylosing spondylitis in the u.s. | AbbVie news center. June 25, 2021. Accessed June 25, 2021. https://news.abbvie.com/news/press-releases/abbvie-provides-update-regarding-rinvoq-upadacitinib-in-psoriatic-arthritis-and-ankylosing-spondylitis-in-us.htm?view_id=5591

2. AbbVie submits regulatory applications to FDA and EMA for RINVOQ (upadacitinib) for the treatment of adults with active psoriatic arthritis. AbbVie news center. June 1, 2020. Accessed June 25, 2021. https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-rinvoq-upadacitinib-for-treatment-adults-with-active-psoriatic-arthritis.htm

3. Petronelli, M. AbbVie seeks approval of upadacitinib in U.S., Europe for psoriatic arthritis. Dermatology Times. June 3, 2020. Accessed June 25, 2021. https://www.dermatologytimes.com/view/abbvie-seeks-approval-upadacitinib-us-europe-psoriatic-arthritis