FDA approves Stelara
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating a chronic autoimmune disease that affects 6 million Americans.
The FDA announced Friday the approval of the plaque psoriasis drug Stelara (ustekinumab), made by Horsham, Pa.-based Johnson & Johnson subsidiary Centocor Ortho Biotech.
Plaque psoriasis causes overproduction of skin cells, resulting in thick patches of inflamed, scaly red skin.
“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,” FDA Center for Drug Evaluation and Research Office of Drug Evaluation III director Julie Beitz said in a statement.
Stelara, a monoclonal antibody, works by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation. Because it suppresses the immune system, however, use of the drug poses a risk of infection.