Home » Drug Information » Recently Approved Drugs » 2001
Medical Areas: Dermatology/Plastic Surgery
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Novartis
Approval Status: Approved December 2001
Treatment Area: Atopic dermatitis
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.
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.
Adverse events associated with the use of Elidel may include
(but are not limited to) the following:
- Application site burning
- Headache
- Cold-like symptoms
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.
For additional information on Elidel, please visit
Novartis.