If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Study Finds Elidel(R) (Pimecrolimus) Cream 1% Significantly Reduces Frequency of Atopic Dermatitis (Eczema) Flares in Infants EAST HANOVER, N.J. -- August 13, 2002 -- A study published in the August issue of the Journal of Allergy and Clinical Immunology demonstrates that treatment of atopic dermatitis (also known as eczema) with Elidel® (pimecrolimus) Cream 1% at the earliest signs or symptoms of the disease significantly reduced the frequency of flares and improved overall control of eczema in infants. Additionally, the data show that Elidel was effective in the long-term control of pruritus (itching) and the inflammatory signs of eczema. Atopic dermatitis almost always begins in childhood, usually during infancy. Physicians estimate that 65 percent of eczema patients are diagnosed in the first year of life and 90 percent of patients experience it before age five. "These results indicate that Elidel may offer significant therapeutic advantages over other treatment strategies in the long-term management of chronic eczema in infants and young children," said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology, Children's Hospital, San Diego and Clinical Professor of Pediatrics and Medicine (Dermatology), University of California, San Diego. "A steroid-free therapy like Elidel provides a new alternative for this difficult-to-treat young patient group." Study Details The 12-month, multi-center, double-blind controlled trial studied 251 infants (3-23 months old). The study compared the safety and efficacy of a long-term Elidel treatment regimen with a current widely accepted conventional therapy regimen of emollients and, when necessary, moderately potent corticosteroids, assessing the long-term safety and efficacy of Elidel. In both treatment groups, emollients were used to treat underlying dry skin. Caregivers applied either Elidel or placebo cream at the earliest signs or symptoms of the disease. Topical corticosteroids of mid-potency were used by both treatment groups to treat any severe flares. Results of this study showed that Elidel significantly reduced the incidence of flares over both six and 12 months. The proportion of patients who completed with no flares was approximately twice as high in the Elidel group compared with the control group (67.6% versus 30.4%, during the first 6 months; 56.9% versus 28.3%, over the full 12 months). The study also demonstrated Elidel to have a steroid-sparing effect. Overall, corticosteroid use was substantially lower in the Elidel group: 63.7% of the Elidel group used no corticosteroids during the 12-month study compared with 34.8% of patients in the control group. Elidel was found to be safe and well tolerated; there were no clinically significant differences in the incidence of adverse events between Elidel and the control group. About Elidel Elidel is the first steroid-free prescription cream for mild to moderate eczema patients as young as two years old. It is approved for the short-term and intermittent long-term treatment of mild to moderate eczema in non-immunocompromised patients, for whom conventional therapies are inadvisable because of potential risks, inadequate response, or intolerance. Currently, eczema affects up to 17% of the U.S. population. Mild to moderate sufferers make up the vast majority of this eczema patient population. 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 population. Elidel, which was approved by the FDA in December 2001, is available in tubes of 15 g, 30 g and 100 g. The most common side effect on the skin was a mild to moderate, temporary feeling of warmth or burning (occurring in 8% of children aged 2-17 years and in 26% of adults). This side effect was temporary and its occurrences were comparable to those experienced by patients on placebo cream. Other common side effects included headache and cold symptoms. Elidel did not induce contact sensitization, phototoxicity or photoallergy, nor did it show any cumulative irritation. Elidel did not elicit skin atrophy, sometimes seen with long-term topical corticosteroid use. Developed by the Novartis Research Institute, Elidel 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. This release contains certain forward-looking statements, relating to the Company's business, which can be identified by the use of forward-looking terminology such as "may offer," "new alternative," "first," or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the potential benefit of Elidel (pimecrolimus) Cream 1% as evidenced by clinical trial results and FDA approval. Those statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There are no guarantees that the aforementioned events will result in the commercial success of Elidel (pimecrolimus) Cream 1% in any market. Any such success can be affected by, among other things, uncertainties relating to product development, adverse results in clinical trials regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States. About Novartis Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72,600 people and operate in over 140 countries around the world. For further information please consult http://www.pharma.us.novartis.com or http://www.novartis.com. Media Contacts: SOURCE: Novartis
|
