Looking Back on Dermatology's Historic 2023 with Raj Chovatiya, MD, PhD

It has been a year of ups and downs for dermatologists looking to break ground with different skin diseases. In the ever-expanding field of dermatology, 2023 still emerged as a pivotal year marked by major strides and occasional setbacks.

From rare skin diseases such as hidradenitis suppurativa (HS) to more common conditions such as alopecia areata, the treatment space has never had so many options in the armamentarium. While numerous decisions by the US Food and Drug Administration (FDA) have ushered in promising advancements in the field, some treatments have faced unexpected hurdles, underscoring the complexities of innovation in dermatology.

“I continue to say that I think this was the best year yet we've had in dermatology,” Raj Chovatiya, MD, PhD, told HCPLive. “You and I had this conversation last year, and last year we had a crazy number of approvals…I think that it's great that there's such a renewed interest in essentially redefining or better-defining known mechanisms, or completely implementing treatments for new mechanisms of action.”

Chovatiya is an associate professor of dermatology at Northwestern University’s Feinberg School of Medicine. He spoke with HCPLive about the significance of the most important FDA approvals and other decisions made by the agency, providing his expertise by giving an important insight into this year’s progress.

Most Significant FDA Approvals in 2023

One major decision made in the dermatology space this year was that an approval was granted for beremagene geperpavec (B-VEC) (VYJUVEK), a modified herpes simplex virus type 1 vector designed to help treat the rare but debilitating disease known as dystrophic epidermolysis bullosa (DEB) or ‘Butterfly Disease’.¹

“So the really cool thing about this therapy is it actually leverages a modified herpes simplex 1 virus, one that we know is going to oftentimes be going right for the skin, which is where we really want it to go for,” Chovatiya explained. “And it really limits the pathogenic aspects of the virus, and then it non-permanently delivers functional type 7 collagen.”

Another notable success was the FDA approval of ritlecitinib (LITFULO), which received approval for the treatment of severe alopecia areata in individuals aged 12 years and older.² The once-per-day oral medication represents a new therapeutic option for those impacted by this challenging skin condition.

Verrica Pharmaceuticals was also able to secure an approval for VP-102 (YCANTH), marking a significant milestone as the very first drug specifically indicated for molluscum contagiosum.³ This decision addresses the unmet medical need for an effective intervention against the viral-borne skin disease, providing a promising solution for patients dealing with this condition.

Clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%, known as IDP-126 (Cabtreo), also gained FDA approval in 2023 for the treatment of acne vulgaris in patients in the age range of 12 years and older.⁴ The combination medication provided a multifaceted approach to treating acne, combining the efficacy of adapalene, clindamycin, and benzoyl peroxide.

Chovatiya also commented on secukinumab's (Cosentyx) approval for the treatment of HS in adult individuals with moderate-to-severe disease.⁵ This approval expands the therapeutic options available for individuals grappling with the challenges posed by HS, offering a targeted approach for patients.

The last major approval this year Chovatiya noted was for bimekizumab (BIMZELX) for moderate-to-severe plaque psoriasis in adult patients who qualify for systemic or phototherapy interventions, addressing specific needs of individuals dealing with the challenges of moderate-to-severe plaque psoriasis.⁶

Setbacks for Different Treatments

While 2023 was in some ways a solid year for new treatments of many indications, including a few that had been neglected for many years, there were also several decisions made by the FDA in dermatology that did not lead to new approvals for specific drugs.

Chovatiya commented on 2 that were notable, the first being the FDA’s move to provide a Complete Response Letter (CRL) to a supplemental Biologics License Application (sBLA) for dupilumab as a treatment for those with chronic spontaneous urticaria (CSU).⁷ The move was somewhat of a change in course for the drug, given that dupilumab has been considered a breakthrough drug for atopic dermatitis, prurigo nodularis, and eosinophilic esophagitis, among others.

“So in the case of this particular Complete Response Letter, a lot of it was just based on the fact that there really was only one phase 3 trial that had a sort of successful primary endpoint,” Chovatiya said. “There's another trial ongoing that probably we should be reading about very soon, so I don't suspect this to be a long term setback. I think that dupilumab will be in our hands as a treatment for CSU very soon.”

Another notable announcement this year discussed by Chovatiya was made by Eli Lilly and Company, regarding a CRL to lebrikizumab’s BLA for the treatment of atopic dermatitis.⁸ In a similar vein, however, Chovatiya attributed this FDA decision to third party manufacturing more than anything else, as opposed to questions about the efficacy or safety of the drug.

Approvals on the Horizon

Lastly, Chovatiya looked toward the future, pointing out several key decisions that he believes could come into play that would expand the treatment armamentarium of dermatologists.

“One that should be coming any day now is topical roflumilast for seborrheic dermatitis,” he said. “Seborrheic dermatitis is a disease that's never really had approved treatments. It's one that we don't even understand the pathogenesis and mechanism that well, and this is a topical PDE4 inhibitor that is going to be in a novel foam vehicle.”

There are a few more nonsteroidal topical treatments predicted for the near future as well, such as roflumilast and tapinarof for AD. They both involve 2 distinct mechanisms, but Chovatiya noted their convincing data and use of a non-steroidal approach for treating individuals with AD.

“I hesitate to say this has been the best year yet, because 2024 is around the corner, and who knows what that has in store?” Chovatiya said. “But it's really exciting to be practicing dermatology during this age, and the parting sort of bit of advice to leave everyone with is, don't be afraid of the new stuff entering your toolbox.”

References

1. ^{Smith T. FDA Approves B-VEC Topical Gene Therapy for Dystrophic Epidermolysis Bullosa. HCPLive. May 19, 2023. Date accessed: December 8, 2023. https://www.hcplive.com/view/fda-bvec-topical-gene-therapy-dystrophic-epidermolysis-bullosa}
2. ^{Kunzmann K. FDA Approves Ritlecitinib as First Drug for Adolescent Alopecia Areata. HCPLive. June 26, 2023. Date accessed: December 8, 2023.
   https://www.hcplive.com/view/fda-approves-ritlecitinib-first-drug-adolescent-alopecia-areata}
3. ^{Smith T. FDA Approves VP-102 for Molluscum Contagiosum. HCPLive. July 21, 2023. Date accessed: December 8, 2023. https://www.hcplive.com/view/fda-approves-vp-102-molluscum-contagiosum}
4. ^{Smith T. FDA Approves IDP-126 (Cabtreo), First Triple-Combination Drug for Acne. HCPLive. October 21, 2023. Date accessed: December 8, 2023.
   https://www.hcplive.com/view/fda-approves-first-triple-combination-drug-acne}
5. ^{Smith T. What Does the FDA Approval of Secukinumab Mean for Patients with HS? HCPLive. November 1, 2023. Date accessed: December 9, 2023. https://www.hcplive.com/view/what-does-fda-approval-of-secukinumab-mean-for-patients-with-hs-}
6. ^{Kunzmann K. FDA Approves Bimekizumab for Adults with Plaque Psoriasis. HCPLive. October 28, 2023. Date accessed: December 8, 2023.
   https://www.hcplive.com/view/fda-approves-bimekizumab-adults-plaque-psoriasis}
7. ^{Smith T. Lawrence Eichenfield, MD: Responding to FDA Decision Not to Approve Dupilumab for CSU. HCPLive. October 22, 2023. Date accessed: December 8, 2023.
   https://www.hcplive.com/view/lawrence-eichenfield-responding-fda-decision-not-approve-dupilumab-for-csu}
8. ^{Smith T. FDA Issues Complete Response Letter for Lebrikizumab Treatment of Eczema. HCPLive. October 2, 2023. Date accessedL December 9, 2023. https://www.hcplive.com/view/fda-issues-complete-response-letter-lebrikizumab-treatment-eczema}