The number of new dermatologic drug approvals by the U.S. Food and Drug Administration (FDA) increased between 2012 and 2022 compared with prior decades, according to a research letter in JAMA Dermatology.
Nearly half of these drugs were considered first in class or first in indication, and several were deemed clinically useful or to have high added therapeutic benefit by four health technology assessment organizations (HTAs) in Germany, Canada, or France.
Researchers identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022, ranging from two new drugs and 0 new indications in 2012 to eight and seven, respectively, in 2022, the study showed. By contrast, just five new drugs for diseases treated primarily by dermatologists were approved by the FDA between 1999 and 2009.
Among the 52 new drugs, 11 (21%) were categorized as first in class and 13 (25%) as first in indication. Benefit ratings by at least one of the four organizations were available for 38 drugs. Of these drugs, 15 (39%) were rated as clinically useful or having high added therapeutic benefit by any organization. Among the 10 supplemental new indications with ratings by any of the four organizations, three (30%) were rated as clinically useful or having high added therapeutic benefit.
Researchers did not include reformulations of already marketed drugs or indications, such as a new topical formulation of an oral drug.
“The main take-away message here is that there have been more dermatologic drugs approved over the past decade, which is encouraging and beneficial for patients, but the innovativeness of the drugs and their benefit for patients is not as clear,” study author Ravi Gupta, MD, MSHP, an Assistant Professor of Medicine at the Johns Hopkins University School of Medicine in Baltimore, tells TDD. “We need more development of truly innovative drugs that are beneficial for patients beyond existing therapeutic options.”
