Guselkumab Adds PsA Structural Damage Inhibition to Label
The FDA has approved guselkumab for the inhibition of structural joint damage in adults with active psoriatic arthritis. This makes guselkumab the only IL-23 inhibitor confirmed to prevent further structural damage in these patients. The approval is based on a study showing significant benefits compared to placebo.
- ▪Guselkumab is now approved to inhibit structural damage in adults with active psoriatic arthritis.
- ▪It is the only IL-23 inhibitor proven to help stop further structural damage in patients with active PsA.
- ▪The approval is based on a phase 3b study showing a 2.5 times greater inhibition of structural damage compared to placebo.
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The FDA has approved a supplemental biologics license application for the interleukin (IL)-23 inhibitor guselkumab to include evidence for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA), according to a May 28 announcement from Johnson & Johnson, the parent company of guselkumab’s manufacturer, Janssen Biotech.The approval confirms that guselkumab is the only IL-23 inhibitor that has been proven to help stop further structural damage in patients with active PsA, setting it apart from risankizumab — another IL-23 inhibitor approved to treat PsA — and the IL-12/IL-23 inhibitor ustekinumab, which is also approved to treat PsA.
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Excerpt limited to ~120 words for fair-use compliance. The full article is at Medscape.
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