Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients, the federal agency said on its website. The agency added that it still needs more long-term safety data to decide whether the drug increases the risk of cancer.
On Tuesday, an FDA committee plans to seek advice on the drug from outside medical experts. Johnson & Johnson's Centocor Inc. unit is seeking approval for the drug to treat adults with chronic moderate to severe plaque psoriasis.
Ustekinumab injections work by blocking an inflammation-causing protein called tumor necrosis factor (TNF). If approved, ustekinumab would compete with other leading injectable drugs in the market.
Its competitors include Amgen Inc. and Wyeth's Enbrel and Abbott Laboratories Inc.'s Humira as well as J&J's Remicade, which is given by intravenous infusion too.
Psoriasis is a skin disorder that causes scaly red patches. It commonly causes red scaly patches to appear on the skin, which are areas of inflammation and excessive skin production.
Skin rapidly accumulates at these sites and takes a silvery-white appearance. Plaque frequently occurs on the skin of the elbows and knees, but can affect any area including the scalp and genitals.
Psoriasis is hypothesized to be immune-mediated and is not contagious. An estimated 7.5 million Americans have psoriasis.
