The number of dermatologic drugs approved by the U.S. Food and Drug Administration (FDA) between 2012 and 2022 may have increased compared with prior decades, according to a new research letter published by Kamat et al in JAMA Dermatology. Investigators noted that dermatologic drug development has historically been lower than other therapeutic classes as a result of revenue and benefit-to-risk ratios; however, recent advancements in the field of dermatologic research have allowed for therapeutic innovations. In the new analysis, investigators used the annual FDA lists of new molecular entity approvals, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles to identify 52 new and 26 supplemental new dermatologic indications for prescription topical and systemic drugs approved from January 1, 2012, to December 31, 2022. After categorizing the drugs into nine therapeutic areas, the investigators determined whether they were incorporated into the World Health Organization Model Lists of Essential Medicines and the FDA’s expedited development or regulatory review programs. They then evaluated each drug’s degree of innovation based on five proxy measures—including FDA innovation designation, clinical usefulness ratings by an independent drug assessor, and benefit ratings by health technology assessment. The investigators found that 21% (n = 11) of the new dermatologic indications were categorized as first-in-class and 25% (n = 13) were categorized as first-in-indication. Among the 38 drugs with benefit ratings, 39% (n = 15) were rated for their clinical utility or high added therapeutic benefit compared with 30% (n = 3) of the supplemental new dermatologic indications. The new findings suggest that patients with skin diseases may have more therapeutic options now than they had a decade prior and highlighted new opportunities to develop therapies for patients with unmet needs.
January 03, 2024