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Home » Drug Information » FDA-Approved Drugs » 2001
Medical Areas: Dermatology/Plastic Surgery

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Drug Information

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Drug Name: Elidel

Company: Novartis
Approval Status: Approved December 2001
Treatment Area: Atopic dermatitis

General Information

Elidel is approved for the treatment of atopic dermatits in adults and children ages two years and older. This topical cream should be applied twice-daily. Elidel is the first non-steroid prescription for mild to moderate atopic dermatitis for use in children and adults and is one of the first new treatments since topical corticosteroids were introduced almost 50 years ago.

Commonly known as eczema, atopic dermatitis is an itchy skin condition affecting up to 17 percent of the US population, or more than 40 million Americans. Eczema primarily affects children and may last until the late teenage years or even for life. Ninety percent of sufferers experience symptoms before reaching the age of five.

Clinical Results

The approval of Elidel is based on results from clinical trials in more than 1,700 pediatric and adult patients. Elidel was shown to relieve itching and redness associated with eczema within eight days of starting treatment.

Side Effects

Adverse events associated with the use of Elidel may include (but are not limited to) the following:


  • Application site burning
  • Headache
  • Cold-like symptoms

Mechanism of Action

The mechanism of action Elidel (pimecrolimus) exhibits in the treatment of atopic dermatitis is unknown. It has been shown to bind to macrophilin-12 and inhibit the calcium-dependent phosphate, calcineurin. Consequently, the drug inhibits T cell activation by blocking the transcription of early cytokines, as well as prevents the release of inflammatory cytokines.

Additional Information

For additional information on Elidel, please visit Novartis.


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