Check Your List and Consider It Twice: A Recap of 2023 Drug Approvals

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2023 was a robust year of FDA approvals to treat a variety of dermatological conditions. Here is a recap of the drugs and treatments approved to keep in mind for the new year.

Adalimumab biosimilars

Several adalimumab (Humira) biosimilars were approved including Hyrimoz,¹ the Cyltezo autoinjector pen,² Yuflyma,³ and Hadlima.⁴ These approvals have opened up treatment options for patients with plaque psoriasis and hidradenitis suppurativa.

Beremagenege perpavec

Krystal Biotech’s beremagene geperpavec (B-VEC; Vyjuvek) was approved for the treatment of dystrophic epidermolysis bullosa. The approval is based on positive data from 2 placebo-controlled clinical trials, GEM 3 (NCT04491604) and GEM1/2 (NCT03536143).⁵

Bimekizumab

Bimekizumab (Bimzelx, UCB) was approved for the treatment of adults with moderate to severe plaque psoriasis who are also candidates for phototherapy or systemic therapy, making bimekizumab the first and only approved IL-17A and IL-17F inhibitor for this indication.⁶

VP-102

Verrica Pharmaceutical’s VP-102 (Ycanth) was approved for the treatment of molluscum contagiosum. VP-102 is a drug-device combination that contains a GMP–controlled formulation of cantharidin 0.7% w/v and gentian, a surgical dye meant to clearly mark treated lesions. VP-102 is the first FDA-approved drug for the treatment of molluscum contagiosum and offers dermatology providers and patients a precise in-office treatment.⁷

IDP-126 gel

IDP-126 gel (Cabtreo; clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) was approved for the treatment of patients with acne. This makes IDP-126 gel the first FDA-approved fixed-dose triple-combination gel for patients with acne vulgaris.⁸

Nivolumab

Bristol Myers Squibb’s nivolumab (Opdivo) was approved as a monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The FDA’s approval is based on results from the pivotal phase 3 CheckMate -76K trial, where nivolumab demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival vs placebo.⁹

Restylane Eyelight

Galderma’s Restylane Eyelight for the treatment of undereye hollows was approved for adult patients over the age of 21. Restylane Eyelight is an undereye hyaluronic acid dermal filler and is the first and only US product formulated with NASHA technology for volume loss.¹⁰

Ritlecitinib

Pfizer’s ritlecitinib (Litfulo) was approved for individuals aged 12 and over with severe alopecia areata. The once-daily oral treatment is the first and only FDA-approved treatment for adolescents with severe alopecia areata. Ritlecitinib is a kinase inhibitor that inhibits Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases.¹¹

Roflumilast cream 0.3%

Arcutis Biotherapeutics’ roflumilast cream 0.3% (ZORYVE) was approved for the treatment of plaque psoriasis in children aged 6 to 11 years. The topical, once-daily steroid-free cream can be applied in intertriginous areas and is designed to simplify plaque psoriasis management for pediatric patients.¹²

Secukinumab

Secukinumab (Cosentyx, Novartis) was approved for the treatment of moderate to severe hidradenitis suppurativa and is currently the only anti-interleukin-17A inhibitor approved for the condition.¹³

Skinvive

Skinvive by Juvedérm (Allergan Aesthetics, AbbVie) is the first hyaluronic acid intradermal microdroplet injection approved to improve skin smoothness in adult patients aged 21 and older. The injectable gel contains local anesthetic lidocaine and was given the green light for all Fitzpatrick skin types, I through VI.¹⁴

Ustekinumab-auub

Ustekinumab-auub (Wezlana), an interchangeable biosimilar to ustekinumab (Stelara), was approved for use in multiple inflammatory diseases including adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.¹⁵

References

1. Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation. News release. Novartis. March 21, 2023. Accessed March 21, 2023. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation#:~:text=Basel%2C%20March%2021%2C%202023%20%E2%80%93,(adalimumab-adaz)%20injection
2. Cyltezo, first and only FDA-approved interchangeable biosimilar to Humira, now commercially available in the US. News release. Boehringer Ingelheim. July 1, 2023. Accessed July 1, 2023. https://www.boehringer-ingelheim.com/us/press-releases/interchangeable-biosimilar-now-available-us
3. Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar. News release. Healthcare Celltrion. May 24, 2023. Accessed May 25, 2023. https://www.celltrionhealthcare.com/board/en_newslist/102
4. Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application (SBLA) for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira. News release. GlobeNewswire. November 7, 2023. Accessed November 7, 2023. https://www.globenewswire.com/news-release/2023/11/07/2775667/0/en/Samsung-Bioepis-Organon-Announce-FDA-Acceptance-of-Supplemental-Biologics-License-Application-sBLA-for-Interchangeability-Designation-for-HADLIMA-adalimumab-bwwd-a-Biosimilar-to-Hu.html
5. FDA approves first topical gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa. News release. FDA. May 19, 2023. Accessed May 19, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-topical-gene-therapy-treatment-wounds-patients-dystrophic-epidermolysis-bullosa.
6. Bimzelx approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. News release. UCB. October 18, 2023. Accessed October 18, 2023. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis
7. Verrica Pharmaceuticals announces FDA approval of Ycanth (cantharidin) topical solution as the first FDA approved treatment of pediatric and adult patients with molluscum contagiosum. News release. Verrica Pharmaceuticals. July 21, 2023. Accessed July 21, 2023. https://verrica.com/press_release/verrica-pharmaceuticals-announces-fda-approval-of-ycanth-cantharidin-topical-solution-0-7/
8. FDA approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older. News release. Bausch Health Companies Inc. October 20, 2023. Accessed October 20, 2023. https://ir.bauschhealth.com/news-releases/2023/10-20-2023
9. US Food and Drug Administration approves Bristol Myers Squibb’s nivolumab for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma. News release. Bristol Myers Squibb. News release. October 13, 2023. Accessed October 13, 2023. https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Approves-Opdivonivolumab-as-Adjuvant-Treatment-for-Eligible-Patients-with-Completely-Resected-Stage-IIB-or-Stage-IIC-Melanoma1/default.aspx
10. Galderma receives FDA approval for its newest hyaluronic acid filler, Restylane Eyelight. News release. Galderma. June 5, 2023. Accessed June 5, 2023. https://www.galderma.com/GaldermaFDAapprovalforRestylaneEyelight
11. FDA approves Pfizer’s Litfulo (ritlecitinib) for adults and adolescents with severe alopecia areata. News release. Businesswire. June 23, 2023. Accessed June 26, 2023. https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata
12. FDA approves Arcutis’ Zoryve (roflumilast) cream 0.3% for the treatment of psoriasis in children ages 6 to 11. News release.Arcutis Biotherapeutics. October 6, 2023. Accessed October 6, 2023. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment
13. Novartis. FDA approves Novartis Cosentyx as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade. News release. October 31, 2023. Accessed October 31, 2023. https://www.novartis.com/us-en/news/media-releases/fda-approves-novartis-cosentyx-first-new-biologic-treatment-option-hidradenitis-suppurativa-patients-nearly-decade.
14. AbbVie. Skinvive by Juvéderm receives U.S. FDA approval. News release. PR Newswire. May 15, 2023. Accessed May 15, 2023. https://www.prnewswire.com/news-releases/skinvive-by-juvederm-receives-us-fda-approval-301824129.html.
15. FDA approves interchangeable biosimilar for multiple inflammatory diseases. News release. FDA. October 31, 2023. Accessed November 1, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases