Rinvoq Approved for Active Ankylosing Spondylitis
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
The approval was based on data from the phase 2/3 SELECT-AXIS 1 and the phase 3 SELECT-AXIS 2 trials.
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
The approval was based on data from 2 pivotal phase 3 studies, which compared Skyrizi to placebo in adults with active PsA who had an inadequate response or were intolerant to biologic therapy and/or nonbiologic DMARDs.
The approval was based on data from the 2-year phase 3 JUNIPERA study that evaluated secukinumab in pediatric patients aged 2 to 17 years with a confirmed diagnosis of ERA or JPsA.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
The ongoing phase 3 BE MOBILE 2 study compared the efficacy and safety of bimekizumab to placebo in 332 adults with active ankylosing spondylitis.
The approval was based on data from a phase 3 study which evaluated tofacitinib in adults with active AS who had an inadequate response to at least 2 NSAIDs.
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
The phase 3 COSMOS study evaluated the efficacy and safety of guselkumab in 285 adults with active PsA who had an inadequate response to anti-tumor necrosis factors.
Findings showed that treatment with secukinumab resulted in a 72% reduction in the risk of flare at week 104 compared with placebo.