Psoriasis Drug, Stelara, Gets FDA Approval

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The psoriasis drug Stelara (ustekinumab) was given FDA approval yesterday for adults who have a moderate to severe form of psoriasis.

Stelara, manufactured by Centocor Ortho Biotech Inc., is a monoclonal antibody given by injection. After the first shot, patients get another shot four weeks later, and then a shot every 12 weeks. Stelara treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.

Plaque psoriasis is an immune system disorder which affects about 6 million people in the United States. Psoriasis affects the life cycle of skin cells, causing cells to build up rapidly on the surface of the skin, forming thick silvery scales and itchy, dry, red patches that are sometimes painful.

Psoriasis is a persistent, long-lasting (chronic) disease. For some people, psoriasis is just a nuisance. For others, it's disabling, especially when associated with arthritis.

Plaque psoriasis is the most common form. The dry, raised, red skin lesions (plaques) covered with silvery scales can occur anywhere on the body, including the genitals and the soft tissue inside the mouth. The plaques itch or may be painful.

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“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, M.D., director, Office of Drug Evaluation III, in the FDA’s Center for Drug Evaluation and Research.

The FDA approved Stelara is 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.

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 or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

Current treatments for psoriasis include Enbrel, Humira and J&J's older Remicade medicine that is given by intravenous infusion.

Source FDA News Release

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