Sept. 25, 2009 -- The FDA today approved a new biologic drug called Stelara
for the treatment of moderate to severe plaque psoriasis in adults.
Plaque psoriasis is an immune system disorder that results in the rapid
overproduction of skin cells. According to the FDA, about 6 million people in
the U.S. have plaque psoriasis, which is characterized by thickened patches of
inflamed, red skin, often covered with silvery scales.
Stelara is given by injection. After the first shot, patients get another
shot four weeks later, and then a shot every 12 weeks.
An FDA advisory panel recommended the drug for FDA approval in
June 2008. At the time, Stelara was referred to by the name of its active
"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," Julie
Beitz, MD, director of the Office of Drug Evaluation III in the FDA's Center
for Drug Evaluation and Research, says in a news release.
Stelara is a monoclonal antibody, a lab-made molecule that mimics the body's
own antibodies that are produced as part of the immune system. Stelara treats
psoriasis by blocking the action of two proteins that contribute to the
overproduction of skin cells and inflammation.
The FDA approved Stelara based on three studies of 2,266 patients who either
got shots of Stelara or a placebo. Patients who got Stelara were more likely to
achieve the studies' benchmark for reduction in psoriasis, according to
Centocor Ortho Biotech Inc., which makes Stelara.
In a news release, the FDA notes that because Stelara 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 led to hospitalization. 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 states.
The FDA is requiring a risk evaluation and mitigation strategy for Stelara
that includes a communication plan targeted to health care providers and a medication guide for patients.