FDA OKs Long-Awaited Eczema Therapy

WASHINGTON —  The first new type of drug in decades to treat the troubling skin disease eczema won government approval Friday: an ointment named Protopic that can ease the often severe itching in both adults and children.

The Food and Drug Administration cautioned that Protopic shouldn’t be the first therapy for all patients but be reserved for those with moderate to severe eczema who aren’t adequately helped by other treatments or can’t tolerate them.

The manufacturer, Japan’s Fugisawa Healthcare, plans to begin shipping the prescription cream in February, but it refused to disclose the price.

Eczema is a skin inflammation that causes itching and oozing lesions that recur often, sometimes starting in infancy and plaguing patients throughout their lives. The cause is unknown, 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 pills are common treatments. Doctors caution that steroid medications, even cream versions, can cause serious side effects and must be used carefully.

So patients have long hoped for the immune-suppressing drug, 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 contribute to skin inflammation.

In clinical studies, 28% to 37% of patients who used Protopic daily for three months found it cleared up most of their eczema outbreaks, compared with only 7% who had success with a dummy cream.

It was not a cure: Once people quit using the cream, eczema gradually returned. So far, the FDA can say only that it’s safe to use for a year; Fugisawa agreed to conduct longer-term safety studies.

FDA medical officer Dr. Martin Okun said users should stay out of the sun. Some scientists worry that it might mix with sun exposure to increase the risk of skin cancer.

Protopic should not be used until skin infections are healed, because it could increase risk of certain skin infections, including a serious herpes virus-caused infection called eczema herpeticum.