Pipeline of Promise for atopic dermatitis

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While Janus kinase inhibitors (JAKs) have made headlines as the FDA assesses their efficacy and safety, more options are on the horizon. A constant stream of new therapeutic agents is now navigating the atopic dermatitis (AD) pipeline.

“Over the past two years,” said Peter Lio, MD, who spoke at the National Eczema Association’s virtual eczema exhibit,1 “Not only do we have new treatments that have already made a huge difference in the lives of patients, but more importantly, this is just the tip of the iceberg.2.3 He is Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University Feinberg School of Medicine.

Oral JAK inhibitors

In mid-2021, the FDA extended the Prescription Drug User Fee Act (PDUFA) dates for the following drugs.4-6 However, some oral JAK inhibitors have seen a setback with the September 1 FDA decision to require severe health risk warnings on the JAK inhibitor tofacitinib (Xeljanz, Pfizer), which is used to treat Rheumatoid arthritis, among other conditions. The decision was broadened to include baricitinib (Olumiant, Eli Lilly and Company) and upadacitinib (Rinvoq, AbbVie) in the warning warrant.

“We look forward to these new additions to the AD arsenal as we continue to have unmet needs and patients who are literally strapped for options,” says Lio. “Although there are significant safety concerns with the JAK class of inhibitors, I hope we will be able to carefully review the specific safety data in the AD population in order to better guide our patients in a future. shared decision-making process.

Topical JAK inhibitors

Delgocitinib (LEO) – Phase 3 results in Japanese children show significantly greater reductions in altered eczema area scores and vehicle severity index.7 In the United States, delgocitinib has been accelerated by the FDA for chronic hand eczema.

Topical phosphodiesterase 4 (PDE4) inhibitor

  • Roflumilast (Arcutis) —Phase 3 results in patients aged 6 years and older (NCT04773587, NCT04773600) and 2 to 5 years (NCT04845620) with mild to moderate AD are expected in late 2022.

Ayrl hydrocarbon receptor inhibitor

  • Tapinarof (Dermavant Sciences) —On September 9, Dermavant announced dosing for its first phase 3 patient with AD.8

Injectable biologics

  • Lebrikizumab (Eli Lilly and Company) —In mid-August, the FDA granted the fast-track designation of lebrikizumab in adults and adolescents with AD based on results from phase 3 week 16.9
  • Adtralza (tralokinumab, LEO Pharma) – FDA review continues after the agency requested additional data in April 2021.ten
  • Nemolizumab (Galderma) —Phase 3 results in moderate to severe AD are expected in late 2022 (NCT03985943, NCT03989349) and late 2023 (NCT03989206).

The references:

1. Lio P, Chovatiya R, Schoch J. Now listen to this: the latest news on prescription treatments for eczema. Virtual Eczema Exhibition from the National Eczema Association; August 28, 2021.

2. Lio P. The latest news in Rx treatments for eczema. Virtual Eczema Exhibition from the National Eczema Association; August 28, 2021.

3. Lio P. Biological treatments for eczema. Virtual Eczema Exhibition from the National Eczema Association; August 28, 2021.

4. Pfizer. Pfizer announces the extension of the review of the marketing authorization application for abrrocitinib for the treatment of moderate to severe atopic dermatitis. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-extension-review-new-drug-application. April 7, 2021. Accessed September 10, 2021.

5. Eli Lilly. Lilly and Incyte provide an update on the demand for a new additional drug for baricitinib for the treatment of moderate to severe atopic dermatitis. Https://investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-provide-update-supplemental-new-drug. July 16, 2021. Accessed September 10, 2021.

6. AbbVie. AbbVie is providing an update on Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the United States. Https://news.abbvie.com/news/press-releases/abbvie-provides-update-regarding-rinvoq-upadacitinib-for-treatment-moderate-to-severe-atopic-dermatitis-in-us.htm?view_id= 1310. July 16, 2021. Accessed September 10, 2021.

7. Nakagawa H, Nemoto O, Igarashi A, et al. Delgocitinib ointment in pediatric patients with atopic dermatitis: a phase 3, randomized, double-blind, vehicle-controlled study and a subsequent long-term open-label study [published online ahead of print, 2021 Jun 10]. J Am Acad Dermatol. 2021; S0190-9622 (21) 01116-6. doi: 10.1016 / j.jaad.2021.06.014

8. Dermavant. Dermavant announces the first patient dosed in ADORING, its pivotal phase 3 clinical program for tapinarof for the topical treatment of atopic dermatitis. https://www.dermavant.com/dermavant-announces-first-patient-dosed-in-adoring/. September 9, 2021. Accessed September 10, 2021.

9. Eli Lilly. Lilly’s lebrikizumab significantly improved skin clearance and itching in people with moderate to severe atopic dermatitis in two phase 3 trials. Https://investor.lilly.com/news-releases/news-release-details/ lillys-lebrikizumab-significantly-improved-skin-clearance-and. August 16, 2021. Accessed September 10, 2021.

10. LEO Pharma. Update on the US FDA review of LEO Pharma’s biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis. Https://www.leo-pharma.us/Files/Billeder/leo-us/Press%20Release_FDA_Review_tralokinumab.pdf. April 29, 2021. Accessed September 10, 2021.

Disclosure:

Lio has been a speaker for Sanofi Genzyme, Regeneron Pharmaceuticals, Pfizer, Eli Lilly Company, LEO Pharma, Galderma, Incyte and L’Oréal; member of the advisory board of Almirall, ASLAN Pharmaceuticals, Dermavant Sciences, Sanofi Genzyme, Pfizer, LEO Pharmaceuticals, AbbVie, Eli Lilly and Company, Micreos, L’Oréal, Pierre Fabré, Johnson & Johnson, Level Ex, KP Away, Unilever, Menlo Therapeutics, Theraplex, IntraDerm, Exeltis, AOBiome, Realm Therapeutics, Altus Labs, Galderma, Verrica, Arbonne, Amyris, Bodewell, Yobee Care, Burt’s Bees, MyOR Diagnostics and Kimberly-Clark; researcher for AOBiome, AbbVie, Regeneron Pharmaceuticals and Sanofi Genzyme; patent holder for Theraplex AIM (Splashe Brands, patent pending); and shareholder of LearnSkin, Micreos, Yobee Care, Altus Labs and KP Away.


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