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Posted: June 24, 2008

New Psoriasis Drug Receives Unanimous FDA Panel Approval

A new psoriasis drug that would require less-frequent treatments has won approval by a key FDA regulatory panel for use with adults who suffer from moderate-to-severe psoriasis. Still, the panel cautioned about potential side effects related to cancer and called for more research.


Despite those concerns, panel members and FDA staff hailed the effectiveness of the drug, developed by the Centocor unit of Johnson & Johnson, in treating the non-contagious, lifelong skin disorder that can be debilitating.


"This drug has the potential to be so helpful for patients, and I think it raises an ethical question if we keep it from them," panel member Dr. Lynn A. Drake, of the department of dermatology at Massachusetts General Hospital, told the Dow Jones news agency.


According to the National Institutes of Health, as many as 7.5 million Americans have psoriasis and about 1 million are said to have moderate-to-severe psoriasis. About 10%-30% of all people with psoriasis also develop psoriatic arthritis, which causes pain, stiffness and swelling in and around the joints. Psoriasis itself is characterized by dry, crusty, cracked and red-patched skin.

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 11-0 to unanimously recommend approval of the drug, called ustekinumab, which is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. The full FDA will now take up the panel’s recommendation.


One of the major advantages of ustekinumab is that it requires less-frequent dosing than existing therapies. After an initial boosting phase, ustekinumab would be injected once every three months, while market leader Enbrel needs to be taken twice a week. J&J’s existing blockbuster Remicade (infliximab), which is indicated for psoriasis, is administered every eight weeks, while Abbott Laboratories’ Humira (adalimumab) is taken every other week.


According to the FDA panel, it made its recommendation after reviewing data from what J&J called “one of the largest biologic clinical programs in psoriasis”, including two late-stage trials involving more than 2,000 patients. Results of those studies showed that a majority of patients treated with ustekinumab experienced significant skin clearance within 12 weeks and maintained that status through at least week 76 by using ustekinumab as a maintenance therapy once every 12 weeks.

The panel backed the drug despite evidence from trials in mice that the drug may cause lymphoma cancer after long-term use. The committee recommended that the drug maker be required to track patients taking the drug for any signs of cancer and recommended that doctors administer ustekinumab in their clinics instead of patients taking the drug at home. Enbrel (etanercept) allows self-treatment by patients.

In turn, J&J has suggested setting up a voluntary registry of all patients prescribed the drug and continuing to track participants from its trials for an additional five years. Centocor is currently carrying out more long-term studies on the treatment.

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