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FDA Approves Elidel Cream (Pimecrolimus) For Children With Mild To Moderate Eczema

EAST HANOVER, NJ -- December 14, 2001 -- Novartis Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted marketing approval for Elidel® (pimecrolimus) Cream 1%, the first non-steroid prescription cream for mild to moderate atopic dermatitis in patients aged two years and older.

Commonly known as eczema, atopic dermatitis is an itchy skin condition affecting up to 17 percent of the US population. Research shows that up to 90 percent of all eczema-related visits to doctors in the US are for mild to moderate disease.

Conventional therapies can be ineffective and/or inadvisable for many of these eczema patients. Elidel will soon be available as a treatment option for this patient population. With a US launch anticipated for early next year, Elidel will be one of the first new treatments for eczema since topical corticosteroids were introduced almost 50 years ago.

"More than 40 million Americans suffer from atopic dermatitis," said Thomas Ebeling, Chief Executive Officer of Novartis Pharma AG. "Ninety percent of patients show signs of the disease in early childhood, leading many patients and parents of young children to seek effective treatment, especially to relieve the night-time itching that causes sleep disturbances. Elidel will offer an important new alternative to steroids."

Elidel is approved for the short-term and intermittent long-term treatment of mild to moderate eczema in patients who do not respond well to or may have side effects with conventional treatments. There is no cure for eczema, but Elidel can help control it.

"Elidel is an important new eczema therapy. It is our tenth FDA approval this year, which is an exciting accomplishment for Novartis. Furthermore, Elidel has a safety and efficacy profile in the treatment of mild to moderate eczema that make it suitable for the largest segment of the eczema market," said Paulo Costa, President and Chief Executive Officer, Novartis Pharmaceuticals Corporation. "But we also are committed to further study Elidel in infants, where the need for new therapeutic alternatives is significant."

The US approval was based on results of clinical trials in more than 1700 pediatric and adult patients, where Elidel was shown to relieve itching and redness associated with eczema within eight days of starting treatment. The most common side effect on the skin was a mild to moderate, temporary feeling of warmth or burning (occurring in 8 percent of children aged two to 17 years and in 26 percent of adults). Other common side effects included headache and cold-like symptoms. These side effects were temporary and their occurrences were comparable to those experienced by patients on placebo cream. Elidel did not induce contact sensitization, phototoxicity or photoallergy, nor did it show any cumulative irritation. Elidel did not elicit skin atrophy like that from topical corticosteroid use.

"This is a welcome new treatment option for the mild to moderate patient population, who make up the vast majority of eczema cases," said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Children's Hospital, San Diego. "Elidel is proven to be effective and safe in adults and children, with a low incidence of application site burning. This is important news for eczema patients already suffering from considerable skin discomfort."

Eczema is a disease that primarily affects children and may last until the late teenage years or even for life. In fact, 90 percent of sufferers experience symptoms before they reach the age of five. In addition to the physical discomfort, eczema can cause severe psychological and emotional distress. Many patients, especially children, report that eczema makes them feel 'different' and/or isolated and can impact many aspects of day-to-day life.

Elidel, which was discovered by the Novartis Research Institute, may be used on all skin surfaces, including delicate areas such as the face, neck and skin folds. The active ingredient is pimecrolimus, which is derived from ascomycin, a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus. Pimecrolimus selectively blocks the production and release of cytokines from T-cells. These cytokines in the skin cause the inflammation, redness and itching associated with eczema. Elidel will be available in tubes of 15 g, 30 g and 100 g. The product is currently undergoing regulatory review in Europe, where applications for marketing authorizations were filed earlier this year (in Denmark and Switzerland), and in Canada.

SOURCE Novartis Pharmaceuticals

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