FDA Approves New Psoriasis Drug

The FDA has approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.
Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the US have plaque psoriasis, which is characterized by thickened patches of inflamed, red skin that's often covered with silvery scales.

"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, director of the Office of Drug Evaluation III, part of the FDA's Center for Drug Evaluation and Research.

Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body's own antibodies produced as part of the immune system. The medication treats psoriasis by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation.

Three studies of 2,266 patients evaluated Stelara's safety and effectiveness.

Since 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 lead 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 is requiring a risk evaluation and mitigation strategy (REMS) for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

Stelara is manufactured by Centocor Ortho Biotech Inc., a subsidiary of Johnson & Johnson.

Contact:
Karen Riley
301-796-4674
karen.riley@fda.hhs.gov