Innovations in development of dermatologic treatments may have increased over the prior decade (2012-2022), according to a new research letter, though it is clear that there are opportunities to develop more effective agents and especially for those with unmet therapeutic needs.¹

These findings resulted from a recent analysis led by Samir Kamat, MD, from the Icahn School of Medicine’s Department of Medical Education at Mount Sinai in New York.

Kamat and colleagues noted that treatment development in the US has continued to be disproportionately low as opposed to other therapeutic classes as a result of lower potential revenue, with only 5 new being approved by the US Food and Drug Administration (FDA) in the decade between 1999 - 2009.

“However, over the past decade, opportunities for innovation in dermatologic drug development may have changed,” Kamat and colleagues wrote. “This cross-sectional study characterized the frequency and degree of innovation of new dermatologic drugs approved by the FDA from 2012 to 2022.”

Background and Findings

The investigators looked at the newly-approved dermatologic indications for systemic and prescription topical drugs, implementing FDA lists of new molecular entity approvals. They also looked at data from the Centers for Medicare & Medicaid Services CenterWatch and at other peer-reviewed studies.

The research team’s work lasted from January 2012 - December 2022, with the team placing the different treatments into a total of 9 therapeutic areas. They then worked to assess their inclusion in World Health Organization (WHO) Model Lists of Essential Medicines, as well as the FDA's programs for expedited development or regulatory review.

The drug list was reviewed by 2 of the investigators. The team sought to gauge each treatment’s level of overall innovation, using previously-established systems that were grounded in 5 distinct proxy measures.

These included FDA innovation designation that was also adjusted for drug approval to account for first in indication. They also looked at clinical usefulness ratings drawn from an independent French assessor of drugs.

Benefit ratings from health technology evaluation agencies found in Canada, France, and Germany. Descriptive statistics were also implemented to compute yearly data on drug approvals for dermatologic diseases based upon the measures of innovation.

Overall, the research team found a total of 52 new treatment applications and 26 supplemental new indications that had been given an approval by the FDA for use in dermatology from 2012 - 2022. Approvals ranging from 2 new drugs and 0 new indications in 2012 to 8 and 7, respectively, in 2022.

Among the 52 new ones identified by the team, they found that 21% had been classified as first in class. They also reported that 25% had been the first in their unique indication.

The investigators noted that ratings that were used to evaluate the drugs’ benefits from a minimum of 1 of the 4 groups mentioned were accessible for 38 of the treatments. Out of these, the research team found that 39% were assessed as clinically-useful or possessing high added therapeutic benefit by any organization.

The team also found that 30% of the 10 supplemental new indications were deemed clinically useful or having high added therapeutic benefits.

“Prior studies found few markers of innovation, such as priority review or orphan designation, among topical medications approved from 2000 to 2014,” they wrote. “Further development of HTAs, particularly in the US, and more active comparator trials for drugs that are not first in class may incentivize further innovation by identifying the drugs that offer the greatest value compared with existing therapies.”_^2,3

References

1. ^{Kamat S, Ungar B, Agarwal A, Wan J, Ross JS, Gupta R. Innovation in Development of Dermatologic Drugs Approved by the US Food and Drug Administration Between 2012 and 2022. JAMA Dermatol. Published online December 20, 2023. doi:10.1001/jamadermatol.2023.5036.}
2. ^{Walter JR, Xu S. Topical drug innovation from 2000 through 2014. JAMA Dermatol. 2015;151(7):792-794. doi:10.1001/jamadermatol.2015.0231.}
3. ^{Barbieri JS, Tan JKL, Adamson AS. Active comparator trial designs used to promote development of innovative new medications. Cutis. 2020;106(3):E4-E6. doi:10.12788/cutis.0067.}