FDA Approvals, Highlights, and Summaries: Rheumatology

February 24, 2021

Notable approvals

Tremfya (guselkumab) - Indicated for active psoriatic arthritis

Xeljanz (tofacitinib) - Indicated for active polyarticular course juvenile idiopathic arthritis for children aged 2 years and older

Simponi Aria (golimumab) - New indication for active polyarticular course juvenile idiopathic arthritis in children aged 2 years and older; additionally, indication for psoriatic arthritis extended to include patients aged 2 years and older

Ilaris (canakinumab) - Treatment of active Still disease, including adult onset

Taltz (ixekizumab) - New indication for active nonradiographic axial spondyloarthritis with objective signs of inflammation

Cosentyx (secukinumab) - Also approved for nonradiographic axial spondyloarthritis

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