Atopic dermatitis safety concerns affect drug sales

Novartis' Elidel, a topical calcineurin inhibitor, initially enjoyed high sales in atopic dermatitis due to its good side effect profile and effective marketing campaign. However, the brand has been in steady decline since fears of a theoretical malignancy risk arose in 2004. The FDA subsequently imposed a black box warning for Elidel and Astellas' rival product Protopic, despite the fact that the concerns were was based on theoretical risk and not on clinical evidence. According to company reported data, total global sales of Elidel fell 23% from 2004 to 2005, managing only $270 million. The Novartis end-of-year report for 2006 indicated that full-year sales of Elidel had fallen further to $179 million.


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