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Eczema Drug Clears One Hurdle to Approval


WASHINGTON — The first new type of drug in decades to treat the troubling skin disease eczema moved a step closer to market last week as the government's scientific advisors unanimously declared Protopic ointment effective for both adults and children.

But the Food and Drug Administration's advisory committee stopped short of declaring Protopic a first-line alternative to other eczema treatments such as corticosteroids.

Instead, the advisors decided, Protopic should be reserved for patients whose eczema is not adequately helped by other therapies until doctors have more information about how safe it is to use the new cream for long periods of time.

The FDA is not bound by its advisors' decisions but typically follows them. Protopic's manufacturer, Japan's Fugisawa Healthcare, expects a decision in early December. FDA officials signaled they view the drug as promising.

Because it is a unique type of therapy, "our anticipation is that it will offer a helpful choice" for a skin disease that is "common, chronic, costly and sometimes very disturbing," said Dr. Jonathan Wilkin, FDA's chief of dermatology drugs.


Eczema is an itchy skin inflammation that recurs, sometimes starting in infancy and plaguing patients throughout their lives. No one knows what causes it, although people with allergic disorders seem at higher risk.

There is no cure, but corticosteroid creams, antihistamines and, as a last resort for severe cases, steroid-containing pills are common treatments. But doctors caution that steroid medications can cause serious side effects and must be used very carefully.

Protopic is a cream version of an immune-system inhibitor called tacrolimus that, in oral and intravenous versions, already is used to help prevent rejection in organ transplant recipients. The theory is that the cream version helps eczema by inhibiting immune-system cells that may be overactive in the skin inflammation.

In studies, from 35% to 41% of adults who used Protopic daily for three months found it cleared up most of their eczema, contrasted with only 7% who had success with a dummy cream. About 36% of children who tested the drug had similar success.

It was not a cure: Once people quit using the cream, their eczema did gradually recur, Wilkin said.

There were no serious side effects linked to the drug during testing, although patients frequently reported burning and stinging as they rubbed in the cream. But because the drug inhibits the skin's immune system, the advisors called for studies to make sure that use would not increase skin cancer risk.

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