New Drugs and New Molecular Entities in Dermatology

Abstract

To identify and analyze the possible reasons that so few drugs with new molecular entities (NMEs) are first developed for "dermatologic diseases," especially diseases treated primarily by dermatologists. Systematic review and analysis. IMS Health (the pharmaceutical industry worldwide product database) was searched using the terms first launch, topical, and skin/dermatological for the preceding decade. These terms were used for inclusion but not exclusion so that intravenous and oral agents were also identified if they were for skin or dermatologic use. The US Food and Drug Administration (FDA) New Molecular Entities Drug and New Biologic Approvals Web site for the 10 years from 1999 to 2009 was examined for approval of dermatologic agents. To determine the frequency of drug development for dermatologic drugs compared with other fields, the total number of NMEs by therapeutic category for the 5-year period 2005 to 2009 was assessed. Worldwide, the total number of NMEs for diseases treated primarily by dermatologists for almost a decade was 13. Using the FDA Web site, 5 NMEs for diseases treated primarily by dermatologists were approved in 10 years. The major factors precluding NME development for dermatologic diseases seem to be (1) the economic potential of dermatologic drugs, (2) the benefit-to-risk relationship, (3) the limited number of surrogate end points and "soft" semiquantitative end points, and (4) the limited or inadequate basic knowledge of the pathophysiologic characteristics of skin diseases.