To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Protopic (Tacrolimus) Non-Steroidal Ointment For Eczema URL: http://www.pslgroup.com/dg/1ED342.htm Doctor's Guide December 11, 2000
DEERFIELD, IL -- December 11, 2000 -- 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 today 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% concentration of tacrolimus ointment was approved for the treatment of adults and the lower 0.03% 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. "Today's 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. Conventional therapies for eczema have been limited and variable outcomes have been reported. Routine treatment frequently includes the use of steroid creams applied to the skin. Steroids have been associated with side effects including: skin thinning, stretch marks and skin discoloration. Physician and patient satisfaction has been disappointing. Protopic offers physicians another treatment option when conventional treatment is deemed inadvisable because of the potential risks associated with them, or when patients are not adequately responsive to or intolerant of conventional therapies. Similar to other dermatological products currently on the market, Fujisawa advises that patients practice safe sun techniques to avoid direct exposure to natural or artificial sunlight. Some patients reported skin burning and itching associated with the application of Protopic however, the incidences of these events decreased as the disease improved. Eczema is a chronic, life-altering disease characterized by painfully red, swollen, itchy, flaky skin. In some cases the itching and redness is so vast and intense that sufferers will scratch themselves until they bleed, increasing the risk of secondary infection. The majority of eczema cases are diagnosed in early childhood. While 40 percent of children suffering from eczema outgrow the disease, others live with it throughout their lives. Since 1970 the prevalence of atopic dermatitis has nearly tripled. Studies show that the steady increase of this chronic condition is generally attributed to irritants and allergens that trigger the immune system. Emotional factors such as stress can also influence and worsen the condition. In addition to the physical symptoms, atopic dermatitis also diminishes the quality of life of patients and their families. For sufferers, especially teenagers, the visibility of eczema flares can lead to low self-esteem and often the inability to interact with others. Recent survey data from the National Eczema Association for Science and Education states that 56 percent of respondents feel embarrassed or self-conscious in public during a flare and 80 percent experience disrupted sleep. Atopic dermatitis sufferers and their families also say that leisure activities in their daily lives, such as playing sports or taking family vacations, are also disrupted. To address the emotional effects of eczema, Fujisawa Healthcare conducted Quality of Life Studies as part of their clinical trials that were presented in March 2000 at the 58th meeting of the American Academy of Dermatology (AAD). Patients, parents or guardians involved in the 12-week medical study completed a survey that scored the physical and emotional improvement of the patient and family in question. "Our Quality of Life (QOL) assessment found that eczema sufferers treated with Protopic had significant improvements in sleep, symptoms, everyday activities and feelings," says Dr. Lynn A. Drake, Massachusetts General Hospital, Harvard Medical School. "I've suffered emotionally and physically from eczema since I was a baby," says Sarah Robb, fourteen year-old eczema sufferer. "I couldn't sleep, I couldn't wear tank tops to school without embarrassment and I even had to give up going to summer camp with the other kids. Protopic ointment has cleared my skin. I'm wearing tank tops to school and taking part in all the activities, even camp, that I couldn't before. I feel like I can live normally again -- and so can my family." --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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