New Psoriasis Drug Approved by FDA

The Food and Drug Administration (FDA) approved a new drug used in the treatment of moderate to severe psoriasis on September 25, 2009. The approval of Stelara (ustekinumad) occurred following positive results from three studies evaluating the safety and efficacy of the drug on 2,266 patients.

The drug is produced in a laboratory and imitates antibodies produced as part of the immune system in the body. Stelara treats psoriasis, a common skin condition that typically causes irritation and redness, by blocking two proteins in the body that aid in the overproduction of inflammation and skin cells. 

Dr. Julie Beitz, Director of the Office of Drug Evaluation III for the FDA’s Center for Drug Evaluation and Research says the approval of Stelara “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.”

According to the FDA, approximately 6 million Americans have plaque psoriasis, a non-contagious condition that typically surfaces between the ages of 15 and 35. Symptoms of psoriasis include flaky or irritated patches of skin that may be pink or red in color, raised and thick or dry with flaky skin that may resemble scales.

The FDA cautions against Stelara’s risk of infection stating, “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’s press release announcing the approval of Stelara notes that the organization is also requiring a risk evaluation and mitigation strategy for the drug, including a communication plan targeted to healthcare providers in addition to a medication guide for patients.