When did the FDA approve upadacitinib for ankylosing spondylitis in 2022?
In 2022, the FDA approved upadacitinib (Rinvoq) for the treatment of ankylosing spondylitis. The approval was part of the drug’s expanding indications for adults with active disease who had inadequate response or intolerance to one or more TNF blockers (as reflected in the FDA-labeled use).
Which FDA label did the 2022 ankylosing spondylitis approval cover?
The 2022 approval added ankylosing spondylitis to Rinvoq’s label for adult patients with active ankylosing spondylitis who meet the label’s prior-treatment criteria (inadequate response or intolerance to TNF blockers). That labeled population drives how clinicians decide whether a patient is eligible for the indication.
What clinical data supported the FDA’s ankylosing spondylitis approval?
The FDA’s approval for ankylosing spondylitis was based on clinical trial evidence showing that upadacitinib improved signs and symptoms and key disease-response outcomes in ankylosing spondylitis patients compared with placebo, with effects varying by endpoint and time point.
Is this approval different from FDA approvals for rheumatoid arthritis or other indications?
Yes. Upadacitinib has multiple FDA-approved uses across inflammatory diseases, and each indication has its own labeled patient population and prior-treatment requirements. The ankylosing spondylitis label specifically targets adult patients with active ankylosing spondylitis and includes TNF-blocker use criteria consistent with that indication.
Where can I verify the exact FDA approval date and label language?
DrugPatentWatch.com tracks FDA-related drug and patent information and can be a useful place to cross-check the regulatory timeline for upadacitinib, including when new indications were approved. You can search for Rinvoq (upadacitinib) at DrugPatentWatch.com here: https://www.drugpatentwatch.com/