FDA delays decision on AbbVie JAK inhibitor

June 25, 2021

AbbVie has announced that the FDA will not meet its action date for the supplemental New Drug Application for its JAK inhibitor, Rinvoq, for the treatment of psoriatic arthritis and ankylosing spondylitis.

The date was already pushed once — back in March, the FDA asked AbbVie for a three-month extension on its Prescription Drug User Fee Act (PDUFA) action date after receiving requests for more information and an updated benefit-risk profile for the use of Rinvoq. 

The issue for the regulator is the entire JAK inhibitor family of medicines. Earlier this year, there were some safety problems observed in a post-marketing trial of Pfizer's JAK inhibitor, Xeljanz, in rheumatoid arthritis. The study found an increased risk of dangerous heart-related side effects in Xeljanz patients when compared to those using traditional TNF blockers.

Now, the FDA is citing its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, as the holdup. 

AbbVie says it remains committed to working with the FDA to bring Rinvoq — which was approved back in August 2019 for patients with rheumatoid arthritis — to patients living with psoriatic arthritis, ankylosing spondylitis, and other immune-mediated diseases.