Significant Improvements Seen With Bimekizumab in Ankylosing Spondylitis Trial
The ongoing phase 3 BE MOBILE 2 study compared the efficacy and safety of bimekizumab to placebo in 332 adults with active ankylosing spondylitis.
Arthritis/rheumatic Disorders
Xeljanz/Xeljanz XR Approved for 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.
Stelara Approved for Pediatric Psoriatic Arthritis
The approval is supported by evidence from adequate and well-controlled studies of Stelara.
FDA to Review Biosimilar Hyrimoz High Concentration Formulation
The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF.
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.
FDA to Review Abrilada for Interchangeability With Humira
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.
Skyrizi Gets FDA Approval for Psoriatic 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.
Cosentyx Approved for Enthesitis-Related Arthritis, Juvenile Psoriatic Arthritis
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.
Yusimry, a Humira Biosimilar Product, Gets FDA Approval
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
Rinvoq Labeling Updated to Include Class Warnings Related to JAK Inhibitors
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.
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