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A U.S. Food and Drug Administration (FDA) panel of outside experts has voted unanimously to approve Centocor’s experimental biologic ustekinumab for the treatment the treatment of moderate to severe plaque psoriasis. As Reuters reported:
An experimental Johnson & Johnson drug should be approved for treating adults with moderate or severe psoriasis, an advisory panel unanimously ruled Tuesday.
The ability of the drug, ustekinumab, to relieve symptoms of the skin disorder outweighed concerns treatment might increase the risk of cancer, the outside experts that advise the Food and Drug Administration said.
"It's quite striking how well it works compared to other things that we have available," said panel chairman Michael Bigby, associate professor of dermatology at Beth Israel Deaconess Medical Center in Boston.
But the panel said the manufacturer's post-approval monitoring plans were insufficient to gauge long-term risks. Members also voted 7-4 that the drug should be injected by prescribers rather than patients themselves.
The FDA will consider the advice before making a final decision. The agency usually follows panel recommendations.
… [Most existing biologics for psoriasis] work by blocking an inflammation-causing protein called tumor necrosis factor (TNF).
Ustekinumab blocks interleukin-12 and interleukin-23, two other immune-system proteins linked to inflammation.
FDA reviewers said animal studies showed blocking those proteins increased the chances of developing cancer, which raised concern about the effect in people. …
Panel members said doctors and patients should be informed of the cancer concern, but it was not enough to keep the drug off the market.
"We don't know if it's going to hurt them ... I think ethically we have to make this available" in light of the drug's effectiveness, said Lynn Drake, a dermatologist at Massachusetts General Hospital.
Officials with J&J unit Centocor said no increase in cancer was seen in people studied as long as 18 months and the company would monitor cancer cases after approval.
The prescribing information for the TNF-blocking drugs come with a warning about a possible risk of cancer.
Michael Paranzino, president of Psoriasis Cure Now, appeared at the hearing and spoke to the Committee about the seriousness of psoriasis and the need for additional treatment options. He read excerpts from patient emails testifying to the debilitating nature of psoriasis, and on behalf of Psoriasis Cure Now he urged approval of ustekinumab. He also urged the FDA to allow patients to be given the option to inject the medication at home, rather than requiring the patient to receive the injections at a physician’s office.
Paranzino also expressed disappointment with the FDA for failing to address, in its briefing materials for the committee, the profoundly negative impact that psoriasis can have on a patient’s quality of life. Finally, he urged the FDA and Centocor to agree on a robust, long-term study of the potential safety issues surrounding ustekinumab and for Centocor to see the study through to completion and publication.
The clinical trials showed ustekinumab to be both effective and highly convenient. What’s more, its 18-month safety data appear strong. What remains to be seen is how patients will fare over the long haul, both in terms of its effectiveness and whether any dangers emerge over time that would not be seen this early in a treatment’s use. Additional studies must be undertaken to help us understand the benefits and risks of IL-12/IL-23 inhibitors as psoriasis treatments; and certainly, patients should carefully evaluate with their physician any new treatment before using it.
Abbott is also working on an IL-12/IL-23 inhibitor, ABT-874, but media reports suggest it is 12 to 18 months away from seeking its own FDA approval.
If the FDA approves ustekinumab, it is expected to be available to patients with moderate to severe plaque psoriasis by the end of 2008.
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