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Protopic

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Protopic Immunomodulator

The following articles/news releases are about a new drug called Protopic Ointment. Protopic ointment, an immunomodulator, is currently indicated for the treatment of moderate to severe eczema (atopic dermatitis). Currently, an investigator initiated study is underway with support from Fujisawa Pharmaceuticals of Japan, to evaluate the safety and efficacy of Protopic in the treatment of Vitiligo. Topical immunomodulators alter (down-regulate) the immune response in the skin. Protopic ointment may be useful in curbing the immune response against pigment cells in the area of Vitiligo.

Currently, however, those with Vitiligo should be aware that the Protopic label does not mention "Vitiligo" specifically, and the Food and Drug Administration regulatory requirements do not support the clinical investigation or use of Protopic at this time. We are hopeful that study results will eventually lead to such an approval.

For more information about Protopic as it relates to Vitiligo, please read our new Vitiligo FAQ page (Frequently Asked Questions).

Vitiligo & Pigmentation Institute of Southern California:
Eczema Ointment Shows Promise for Vitiligo Sufferers

LOS ANGELES, Feb 22, 2002 /PRNewswire via COMTEX/

Protopic, the first in a new class of drugs called topical immunomodulators (TIMs) shows promise as an innovative treatment option for Americans with Vitiligo, a difficult skin condition characterized by stark white patches of skin throughout sufferers' bodies caused by a mysterious loss of pigmentation.

"We achieved success with Protopic in restoring pigment to affected areas in 100 percent of patients tested," said Pearl Grimes, M.D., Chair of the Vitiligo & Pigmentation Institute of Southern California and lead investigator of the study presented at the 60th Annual Meeting of the American Academy of Dermatology in New Orleans. "This is an early sample of the database we now have of patients treated with Protopic for Vitiligo. We have experience with more than 150 patients and we have the utmost certainty that Protopic assumes a place in the hierarchy of treatments for vitiligo for children and adults."

The poster presentation included results with six patients ranging from 7 to 38 years of age. Patients applied tacrolimus ointment to affected areas of their bodies twice daily for a period of one to five months. Various degrees of repigmentation were achieved in all patients, with one patient experiencing excellent repigmentation (100 percent) four patients experiencing moderate repigmentation (50-75 percent) and one patient experiencing mild repigmentation (25-50 percent).

Vitiligo can affect anyone, but the condition is more obvious on people with darker skin. Light skinned people usually notice the contrast between areas of Vitiligo and suntanned skin. Overall, Vitiligo affects one or two out of every 100 people. Commonly affected parts of the body include the face, hands, arms, legs and genital areas. Vitiligo is not associated with any other physical health problems, although many people with the distressing condition are afflicted with low self-esteem, depression, job discrimination and other psychological disorders related to their appearance. Although doctors do not know what specifically causes Vitiligo, research indicates that genetics might be a factor.

Protopic (tacrolimus ointment) was approved by the FDA in December 2000 for the treatment of moderate to severe eczema. Tacrolimus is part of a new class of drugs called topical immunomodulators, or TIMs, and was the first new class of treatments for eczema approved by the FDA in more than 40 years. 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.

FDA Approves Protopic (Tacrolimus) Non-Steroidal Ointment For Eczema

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. Protopic is also being tested for use in treating Vitiligo and other skin disorders.

"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."