Horizon Seeks Approval of Pegloticase Plus Methotrexate for Uncontrolled Gout
The sBLA submission is supported by data from the phase 4 MIRROR trial.
Musculoskeletal Disorders
Antisense Oligonucleotide Fast Tracked for Myotubular and Centronuclear Myopathies
The Company is currently evaluating DYN101 in the phase 1/2 UNITE-CNM trial in patients 16 years of age and older with CNM caused by mutations in the MTM1 or DNM2 gene.
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.
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.
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.
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.
Guselkumab Improves Psoriatic Arthritis in Patients With Inadequate Response to TNFi
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.
Flare Risk Reduced With Secukinumab in 2 Types of Juvenile Idiopathic Arthritis
Findings showed that treatment with secukinumab resulted in a 72% reduction in the risk of flare at week 104 compared with placebo.
Urate-Degrading Enzyme Fast Tracked for Hyperuricemia With Gout and CKD
ALLN-346 is an investigational, first-in-class, nonabsorbed, orally-administered enzyme that breaks down urate in the gastrointestinal tract.
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