FDA Close To Approving Eczema Drug

Friday, November 17th 2000, 12:00 am

By: News On 6

WASHINGTON (AP) â€” The first new type of drug in decades to treat the troubling skin disease eczema moved a step closer to market Thursday as the government's scientific advisers 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 like corticosteroids.

Instead, the advisers 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 advisers decisions, but typically follows them. Protopic's manufacturer, Japan's Fugisawa Healthcare, expects a decision early next month. 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 a itchy skin inflammation that recurs often, sometimes starting in infancy and plaguing patients throughout their lives. No one knows just 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 some 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 called T cells that may be overactive in the skin inflammation.

In studies, between 35 percent and 41 percent of adults who used Protopic daily for three months found it cleared up most of their eczema outbreak, compared with only 7 percent who had success with a dummy cream. About 36 percent 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 some burning and stinging as they rubbed in the cream. But because the drug inhibits the skin's immune system, the advisers called for long-term studies to make sure that continued use would not increase patients' risk for skin cancer.