FDA approves Stelara for treatment of psoriasis

October 6, 2009
Allison Tsai

Horsham, Pa. ? The U.S. Food and Drug Administration (FDA) has approved the biologic Stelara (ustekinumab, Centocor Ortho Biotech) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, according to a Centocor press release.

Horsham, Pa.

- The U.S. Food and Drug Administration (FDA) has approved the biologic Stelara (ustekinumab, Centocor Ortho Biotech) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, according to a Centocor press release.

Stelara is a human monoclonal antibody that targets cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), proteins believed to be associated with the development of psoriasis.

The clinical development program for Stelara included more than 2,200 patients and two pivotal phase 3 trials. In each of the trials, a significantly higher proportion of patients receiving either 45 mg or 90 mg of Stelara achieved at least a 75 percent reduction in psoriasis, measured by the Psoriasis Area and Severity Index (PASI), at week 12 as compared to placebo, according to Centocor.

The drug is administered as a subcutaneous injection given at weeks zero and four, followed by a dosing every 12 weeks.

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