Novartis files ASM 981 for treatment of eczema in the US

Non-steroid treatment may offer new options for adult and pediatric patients

19-Dec-2000

Novartis has filed a new drug application (NDA) with the US food and Drug Administration (FDA) for ASM 981 Cream 1%, a unique, new treatment for atopic dermatitis. Atopic dermatitis (also known as atopic eczema) is an increasingly common disease which affects approximately one in five people in the Western world at some time during their lives.1

'The pivotal trials show that our new non-steroid treatment can be used in sensitive areas, such as the face, as well as in babies as young as 3 months,' said Dr Joerg Reinhardt, Global Head of Development at Novartis Pharma. The company expects to file applications for marketing authorization to European health authorities in 2001*.

The US NDA filing is based on clinical studies involving over 2000 patients treated with ASM 981, making it one of the largest development programs ever undertaken for atopic dermatitis. In two randomized, multi-center double-blind studies involving children aged 1-17 years, itching was significantly reduced after only 8 days of treatment with ASM 981 Cream 1%2. The eczema improved to a far greater degree in the ASM 981 group than in those treated only with placebo, as measured by the Eczema Area and Severity Index (EASI). The EASI was reduced by a median of 59% in the ASM 981 group, compared with 14% in patients treated with placebo only.3

In both trials, ASM 981 cream was used on sensitive skin areas such as the face and neck, and was generally well tolerated. The most commonly reported side effect, usually reported during the first 2 weeks of treatment, was mild to moderate sensation of burning or warmth.

ASM 981 is a selective inflammatory cytokine inhibitor developed by Novartis specifically for the treatment of inflammatory skin diseases, such as atopic dermatitis and psoriasis. Topical steroids have been the standard of care for over 40 years. A recent survey4 reported that many patients are concerned about using these steroid medications long term. The mechanism of action of ASM 981 differs from topical steroids in that ASM 981 selectively targets inflammation in the skin while not inducing skin thinning (atrophy) associated with topical steroids. In clinical trials to date, ASM 981 has demonstrated consistently low levels of systemic exposure which also enhances the product's safety profile.

Atopic dermatitis has increased in prevalence over the last 30 years. The disease usually begins in the first year after birth and may persist into the late teens or even later in life. The exact cause is not known but many patients have a family history of asthma, allergic rhinitis or atopic dermatitis.

ASM 981 cream builds on the existing Novartis portfolio of dermatology products which includes Lamisil (terbinafine), a treatment for fungal infections of the skin, hair and nails, and is the company's third- largest selling product world wide.

The forgoing press release contains forward-looking statements containing terminology such as "show", "expects", "has demonstrated". Such forward-looking statements involve known and unknown risks, uncertainties, ongoing clinical trials and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the aforementioned clinical trials will result in the commercialization of any product in any market. Any such commercialization can be affected by, amongst other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general.

https://www.chemeurope.com/en/news/542/novartis-files-asm-981-for-treatment-of-eczema-in-the-us.html