A new option is on the way for the 15 million Americans who currently suffer from the painfully itchy skin disorder atopic dermatitis, more commonly known as eczema. Fujisawa Healthcare Inc, announced that the U.S. Food and Drug Administration (FDA) has approved Protopic (tacrolimus), a non-steroidal topical ointment, for the treatment of the signs and symptoms of moderate to severe eczema. The 0.1 percent concentration of tacrolimus ointment was approved for the treatment of adults and the lower 0.03 percent concentration was designated for the treatment of both children (ages two and above) and adults for short-term and intermittent long-term therapy.
Protopic is the first in a new class of drugs called topical immunomodulators, or TIMs, to be developed in more than 40 years for the treatment of eczema. The approval of this steroid-free option offers significant hope for those experiencing the devastating physical and emotional effects of atopic dermatitis.
FDA approval of Protopic marks a milestone for eczema sufferers and treating physicians," says Dr. Amy Paller, professor of Dermatology and Pediatrics and chief of Medical School in Chicago, Illinois. "As a pediatric dermatologist I see first-hand both the physical and emotional difficulties young eczema sufferers experience. The approval of Protopic finally gives prescribing physicians an effective, non-steroidal option for treating the often painful and frustrating symptoms resulting from eczema."
Protopic's safety and effectiveness was based on 28 worldwide clinical studies of more than 4,000 adults and children (as young as 24 months of age) suffering from moderate to severe eczema. The studies were conducted in the United States, Europe and Japan. Over one-third of the patients were children.
The study data reported that both concentrations of Protopic significantly improved or cleared the signs and symptoms of the condition in more than 2/3 of the patients. In fact, many patients showed marked improvement in just one week of treatment.