FDAnews
www.fdanews.com/articles/203334-fda-delays-decision-on-abbvies-rinvoq-for-psoriatic-arthritis-and-ankylosing-spondylitis
AbbVie logo

FDA Delays Decision on AbbVie’s Rinvoq for Psoriatic Arthritis and Ankylosing Spondylitis

June 28, 2021

AbbVie’s supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib) as a treatment for adults with psoriatic arthritis and ankylosing spondylitis will not be approved by the FDA’s target decision date of the end of June, the company said.

The delay is linked to the agency’s ongoing review of a postmarket study for a similar Janus kinase (JAK) inhibitor, Pfizer’s Xeljanz (tofacitinib), according to AbbVie.

Rinvoq, which the FDA approved in 2019 for treating moderate-to-severe rheumatoid arthritis, has shown strong efficacy and a favorable benefit-risk profile, AbbVie said. The company pledges to continue working with the FDA on Rinvoq’s review.

View today's stories