ROCKVILLE, Md -- September 25, 2009 -- The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara), a biologic product for adults who have a moderate to severe form of psoriasis.
"This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance," said Julie Beitz, MD, Office of Drug Evaluation in the FDA's Center for Drug Evaluation and Research, Rockville, Maryland.
Three studies of 2,266 patients evaluated the biologic's safety and effectiveness.
The FDA approval was primarily based on 2 phase 3 studies in which a significantly higher proportion of patients receiving either ustekinumab 45 mg or 90 mg achieved at least a 75% reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at week 12 compared with patients receiving placebo.
With every-12-week ustekinumab maintenance therapy, the majority of patients achieving a PASI 75 improvement maintained substantial skin clearance for 1 year.
Since ustekinumab reduces the immune system's ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalisation. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.
The FDA is requiring a risk evaluation and mitigation strategy (REMS) for ustekinumab that includes a communication plan targeted to healthcare providers and a medication guide for patients.
SOURCE: US Food and Drug Administration.
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