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Ustekinumab poised to enter the psoriasis market

Nature Biotechnology volume 26, pages 1317–1318 (2008)Cite this article

Later this month, the US Food and Drug Administration (FDA) will decide whether a new psoriasis drug, Stelara (ustekinumab), can enter the market. The human monoclonal antibody (mAb), developed by Johnson & Johnson's subsidiary Centocor, of Horsham, Pennsylvania, was unanimously recommended for plaque psoriasis by an FDA expert panel back in June. By targeting both interleukin (IL)-12 and IL-23, Stelara is the first therapeutic that aims to stop T helper cells from producing interleukin (IL)-17 and other cytokines, which have been implicated in autoimmune responses. Together with several other IL-12/23 blockers under development, Stelara could potentially challenge the markets of tumor necrosis factor (TNF) α-inhibitors currently in use for treating psoriasis.

Expectations surrounding Stelara and other IL-12/23 inhibitors have been rising ever since late-stage human trial data were released. “These drugs produce the most spectacular results we've seen yet,” says Alan Menter, chair of the Psoriasis Research Institute at Baylor University Medical Center, in Dallas. When the FDA's dermatologic and ophthalmic drugs advisory committee reviewed Stelara in June, they evaluated two multicenter, phase 3 clinical trials involving more than 2,000 patients.

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Figure 1: Centocor's mAb Stelara is the first dual-action drug aimed at the p40 subunit of the IL-12 and IL-23 cytokines to treat severe plaque psoriasis.

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    Charlie Schmidt

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Schmidt, C. Ustekinumab poised to enter the psoriasis market. Nat Biotechnol 26, 1317–1318 (2008). https://doi.org/10.1038/nbt1208-1317a

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