FDA Approves Biologic to Treat Psoriasis

The US Food and Drug Administration has approved Stelara (ustekinumab), a biologic manufactured by Centocor Ortho Biotech, Inc. (Horsham, PA),for adults who have a moderate to severe form of psoriasis.

Stelara is a monoclonal antibody that mimics the body’s own antibodies that are produced as part of the immune system. The biologic treats psoriasis by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation.

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 lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There also may be an increased risk of developing cancer.

The FDA is requiring a risk evaluation and mitigation strategy for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

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, often covered with silvery scales.