The Food and Drug Administration wants additional information on Ustekinumab before approving it as a treatment for chronic moderate-to-severe psoriasis, the agency said Friday. More exactly, the agency wants additional information on the producer’s plan for informing physicians and patients about potential risks.

 

Ustekinumab is produced by Centocor Inc., a unit of Johnson & Johnson and is designed to work by inhibiting a type of protein called interleukin. According to experts, the lack of drugs designed to treat psoriasis will give J&J’s a possible profit of $500 million or more.

 

The drug was well tolerated in two large trials, with generally mild side effects that did not require adjustments in the medicine.

 

The FDA asked the company a medication guide and “communications plan” to explain risks and benefits of the medication. The company must also provide details on how it will assess the effectiveness of its communication strategies.

 

“We anticipate responding to the FDA in January 2009,” said Dr. Jerome A. Boscia, the company’s senior vice president for clinical research and development.

 

Psoriazis is a chronic skin disorder, which results from the overproduction of skin cells. It causes red, scaly plaques that may itch and bleed. An estimated 7.5 million people in the United States and 10 million Europeans are living with psoriasis. Nearly one-quarter of the people with the condition have cases that are considered moderate to severe, according to Centocor. Stress, smoking and excessive alcohol are important factors in developing psoriasis or worsening the chronic recurrent condition.