To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Elidel (Pimecrolimus) Cream Approved for Eczema Treatment Use in Babies to Adults in Denmark URL: http://www.pslgroup.com/dg/214E2A.htm Doctor's Guide March 18, 2002
BASEL, SWITZERLAND -- March 18, 2002 -- Novartis announced today that its new atopic eczema treatment, Elidel® (pimecrolimus), has become the first non-steroid prescription cream approved for patients from as young as 3 months of age through to adulthood. The Danish Medicines Agency is the first health authority in Europe to approve Elidel cream for the itching skin condition which is also known as atopic dermatitis. Novartis will seek approvals in other European countries during 2002 under the Mutual Recognition Procedure, and elsewhere around the globe.
"We are delighted with this decision. Elidel is the first non-steroid prescription cream to be approved for treating eczema in babies, children and older patients, and does not carry the risk of steroid-associated side effects such as thinning of the skin. We believe Elidel represents the most significant advance in treating eczema since topical corticosteroids were introduced more than 50 years ago." said Thomas Ebeling, Chief Executive Officer of Novartis Pharma AG." Eczema is an increasingly prevalent condition, with the number of reported cases having risen by 30 percent over the last 30 years."
About 23 percent of people in Denmark, and one in five in the Western world, suffer at some time in their life from eczema, an incurable disease characterized by red, itching skin that can ooze and crust in its most severe form. While most patients, about 60 percent, grow out of the condition by their late teens, others suffer throughout their lives.
Elidel cream is expected to be available in Denmark around mid-year. It is indicated for the short-term treatment of the signs and symptoms of atopic eczema and intermittent long-term treatment to prevent progression to flares in patients aged three months and above. It is approved for use in patients in whom conventional topical corticosteroid therapy is not advisable because of potential risks, or in patients who are not adequately responsive to, or are intolerant of, conventional topical corticosteroid therapy.
"The approval of Elidel for use in babies is particularly welcome because eczema is a condition that typically begins in infancy, with half of all eczema patients being diagnosed before their first birthday. Elidel will give us the option to control atopic eczema in the long term without running the risk of the side effects associated with steroids. This is a remedy that doctors will welcome and I am sure patients will too," said Professor Kristian Thestrup-Pedersen, a world expert on atopic eczema and Professor of Dermatology at the Marselisborg Hospital in Aarhus, Denmark.
The Danish approval is based on clinical trials involving more than 2000 patients which showed that Elidel cream can reduce itching within the first 3 days of treatment. When applied at the first signs or symptoms of eczema, Elidel cream has also been shown to reduce the incidence of flares (severe redness and swelling, which may be accompanied by oozing and crusting of the skin) in 70 percent of infants (aged three to 23 months) and in 61 percent of children aged two to 17 years over six months. In adults, 49 percent of those treated with Elidel cream were able to control their eczema over six months without any steroids.
Elidel cream may be used on all skin surfaces, including delicate areas such as the face, neck and skin folds. The most common side effect reported on the skin was a mild to moderate, transient feeling of warmth or burning (occurring in 7 percent of pediatric patients aged three months to 17 years and in 15 percent of adults). Other common side effects included headache and cold-like symptoms. These effects were temporary and their occurrences were comparable to those experienced by patients on vehicle (placebo) cream.
Elidel cream has already been approved in the USA for patients over two years of age, and is due to be launched there this month. Novartis is in discussion with the US Food and Drug Administration to submit long-term data to support a licence for use in patients under two years.
Elidel cream was discovered by Novartis scientists in Vienna, Austria. Its active ingredient is pimecrolimus, which is derived from ascomycin, a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus. A skin-selective inflammatory cytokine inhibitor, Elidel cream works by selectively blocking the synthesis and release of inflammatory cytokines from T cells in the skin. It is these cytokines that trigger processes leading to the inflammation, redness and itching associated with eczema.
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