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Canada Approves Steroid-Free Elidel (Pimecrolimus) Cream For Eczema

TORONTO, ON -- May 8, 2003 -- Elidel* (pimecrolimus) cream 1%, a new non-steroid prescription cream for the treatment of eczema, has been approved by Health Canada for the short and intermittent long-term treatment of mild to moderate eczema in patients as young as two years old.

Elidel* has been shown to be both effective and safe in a broad range of patients, and can be used without limitation on all skin surfaces, including highly sensitive areas. Furthermore, it has also been proven to have significant therapeutic advantages over conventional therapy, in the long-term management of the disease.

"Elidel* is a major advance in the treatment of eczema," says Dr. Charles Lynde, Dermatologist and Assistant Professor, Faculty of Medicine, University of Toronto. "Ever since the introduction of topical corticosteroids over 50 years ago, physicians have been waiting for an alternative approach that is effective, safe and does not have corticosteroid-related side effects, such as skin thinning."

Over the past 20 years, there has been a dramatic, ten-fold increase in the prevalence of eczema. Currently, approximately 1 in 5 Canadians, over 6 million people, suffer from this chronic condition that is characterized by intense itching, dry skin and inflammation. Mild to moderate sufferers make up the vast majority of eczema patients with approximately 90% of them experiencing first symptoms before the age of 5. As conventional therapies can be inadvisable and/or ineffective for many of these eczema patients, Elidel* serves as a valuable treatment option for this large patient population.

In a study of 200 eczema sufferers from the United Kingdom, 72.5% were concerned about the use of topical steroid due to the risk of side effects such as skin thinning.

Elidel* provides fast relief from itching
Clinical trials have demonstrated that Elidel* provides a rapid and sustained effect in controlling itching, the primary complaint of patients with eczema. In a controlled long-term study in adults, Elidel* relieved itching within the first 2 days of treatment. This same type of relief has also been demonstrated across a diverse patient population in terms of age and severity of disease.

Elidel* can prevent eczema flares
Large, controlled studies have shown that, when applied at the first signs and symptoms of eczema, Elidel* can prevent flares in all age groups and a broad range of patients. In a 12 month, multi-center, double-blind study involving 713 children between 2 and 17 years of age, long-term Elidel* treatment was compared with current conventional eczema therapy. Results of this study showed that Elidel* significantly reduced flare incidence at both 6 and 12 months compared to conventional therapy:

· 61% of Elidel*-treated patients remained flare-free during the first 6 months of the study (vs. 34% of patients in the control group); and
· 51% of children treated with Elidel* remained flare-free for 12 months (vs. 28% of patients in the control group).

"By preventing flares, Elidel* provides significantly better long-term control of eczema than conventional treatment," added Dr. Lynde. "Eczema flares are not only physically painful, but they also have a profound impact on patients' quality of life and emotional well-being."

Study results are similar with adults. A clinical trial involving 192 adult patients showed that the median time to first flare was 144 days in patients treated with Elidel*, compared to 26 days in patients treated conventionally. In total, 45% of patients in the Elidel* group had no flares of eczema during this 6 month study, compared with just 19% of those in the control group.

Elidel* has an excellent safety and tolerability profile
To date, almost 5,000 patients have been treated with Elidel* in clinical trials. Results have shown that Elidel* is well tolerated on all skin surfaces, including the face, neck and skin folds and is not associated with skin atrophy. The incidence of adverse events has been low, the most common being a mild-to-moderate temporary feeling of warmth or burning on the skin where the cream was applied. This occurred in fewer than 8.5% of children and adults.

"What is particularly exciting about Elidel* is the low incidence of application site burning found during clinical trials," concluded Dr. Lynde. "Given that patients report burning as the number one side effect of conventional eczema treatments, with Elidel*, they now have an alternative that is both highly tolerable and efficacious."

Elidel* 1% cream was approved by Health Canada for the short-term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients 2 years of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.

*ELIDEL is a Registered Trademark.


SOURCE: NATIONAL PharmaCom

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