Rockville, Maryland—The US Food and Drug Administration has finally decided that the benefits of Centocor's Stelara (ustekinumab) to psoriasis sufferers outweigh the drug's slight increased risks for infections and cancer. On September 25th the agency approved Stelara for adults with moderate to severe plaque psoriasis. This follows the September 23rd approval by the UK's National Institute for Clinical Excellence (NICE).

“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, Office of Drug Evaluation III, in the FDA’s Center for Drug Evaluation and Research, in a press statement.

Stelara is a monoclonal antibody that blocks interleukin cytokines IL-12 and IL-23, which contribute to the overproduction of skin cells and inflammation.

FDA approval rested on 3 studies of 2,266 patients.

Stelara psoriasis benefits outweigh infection, cancer risks

According to the agency, “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.”

Consequently, the FDA is requiring Centocor to produce 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.

The approved Stelara treatment schedule is two injections four weeks apart, followed by maintenance injections every 12 weeks. A 45-mg dose is recommended for patients weighing 220 pounds (100 kg) or less, 90 mg for patients weighing more.

An FDA advisory committee unanimously recommended approval of Stelara in June 2008, but the agency repeatedly extended its review of the drug, apparently due to questions about the risk of cancer and infections.

Psoriasis patients on Stelara should avoid live-pathogen vaccines

Stelara's label information includes cautions about potential immunosuppression and a warning that patients taking Stelara should live-pathogen vaccines and should be tested for tuberculosis before beginning Stelara.

Analysts expect Stelara (ustekinumab) to be a big winner for Centocor Ortho Biotech Inc. of Horsham, PA, a wholly-owned subsidiary of Johnson & Johnson of New Brunswick, NJ. The drug's advantages over other therapies include showing high efficacy with just 5 doses a year. Main competitors are Enbrel (etanercept), which has to be given twice-weekly, and Humira, which has to be given every two weeks. Analysts predict sales of $600 million for Stelara for the psoriasis indication.

In the UK, less expensive topical treatments for moderate to severe psoriasis are generally favored over biologic drugs, which are used in only 13% of severe cases. In the US, biologics are used in about half of severe cases. Analysts estimate psoriasis drug sales in the 7 major markets at $2.5 billion in 2008 and expect them to reach $3.5 billion, with biologics accounting for over half of that total.

Amgen/Pfizer's Enbrel (etanercept) and Abbott's Humira (adalimumab) currently dominate psoriasis sales, but a head-to head clinical trial found Stelara to be more effective than Enbrel. In addition, Stelara only needs to be administered five times a year, significantly improving on Enbrel's twice-weekly dosing and Humira's fortnightly specification. Given the reluctance of patients to self-inject, and due to the risk of low compliance, Datamonitor believes dosage frequency is a highly relevant factor.