Posted by Michael Wonder on 25 Aug 2020
AbbVie aubmits regulatory application to FDA for Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ASAS 40 response at week 14 compared to placebo.
AbbVie today announced that it has submitted an application for a new indication to the U.S. FDA for Rinvoq (upadacitinib; 15 mg once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis. AbbVie also submitted an application to the EMA for Rinvoq earlier this year for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.
The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which Rinvoq demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.
