Novartis files Elidel® (pimecrolimus, SDZ ASM 981), its novel treatment for atopic eczema, in the European Union

18-Jun-2001

Novartis announced today that it has filed for marketing approval for Elidel® cream (pimecrolimus, SDZ ASM 981) for atopic eczema (also known as atopic dermatitis) in the European Union. The cream can be used with adults and children as young as three months old.

Elidel is the first and only treatment proven to prevent severe flares of atopic eczema and to eliminate or reduce the need for treatment with topical corticosteroids. Developed by Novartis researchers specifically for the treatment of inflammatory skin diseases, Elidel will be one of the first new non-steroid treatments available for atopic eczema in 40 years and used for the short-term treatment and long-term management of atopic eczema.

A skin-selective inflammatory cytokine inhibitor, Elidel targets those cells causing the inflammation, redness and itching of atopic eczema. A new drug application for Elidel is currently under review by the United States Food and Drug Administration (FDA).

"We are excited about the potential of Elidel which we believe offers a much sought-after alternative to treatment with topical corticosteroids," said Thomas Ebeling, CEO of Novartis Pharma. "Many parents and patients are reluctant to use corticosteroids because they fear side effects. Elidel promises to be a safer and effective treatment, relieving itching within a week in many patients. It is proven to reduce the number of severe flares of atopic eczema and offers a new approach to the long-term management of the disease."

Atopic eczema is a chronic inflammatory skin disease that usually starts in infancy. The prevalence has increased by at least 30 per cent in the last 30 years, and has been referred to as a 'major global public health problem' by the International Study on Asthma and Allergies in Childhood (ISAAC).

The Elidel Phase III clinical trial programme involving more than 2,000 patients worldwide aged three months to adulthood was recently completed by Novartis. The majority of the patients were children.

"Until now, the standard treatment for atopic eczema has been skin care with emollients followed by the intermittent use of corticosteroids, but these can have undesirable side effects including skin thinning," said Dr Roger Allen, consultant dermatologist from Queen's Medical Centre, Nottingham, UK. "Elidel will be welcomed as it will provide physicians and patients with an effective treatment option for patients including babies as young as three months, without the side effects of corticosteroids."

https://www.chemeurope.com/en/news/3542/novartis-files-elidel-pimecrolimus-sdz-asm-981-its-novel-treatment-for-atopic-eczema-in-the-european-union.html