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dupilumab new indications

Apr 13
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The AD, HS, and CHE Treatment Landscape

By Sessions

dermatology drug approvals

Unprecedented momentum in dermatology: The past 18 months have brought a wave of FDA approvals that meaningfully expand options for inflammatory skin disease—many supported by trials with substantial representation of patients with skin of color.

At Skin of Color Update, Conference Co-Chair Andrew F. Alexis, MD, MPH, FAAD, highlighted several advances that matter for clinical care and health equity.

Key updates include:

  • Tapinarof 1% cream for atopic dermatitis (now approved for ages ≥2) with diverse trial cohorts and comparable efficacy across racial groups.
  • Roflumilast 0.3% foam for plaque psoriasis (scalp/body) with rapid itch relief.
  • Ruxolitinib extended to children ≥2 years for mild-to-moderate AD.
  • Delgocitinib cream approved for moderate-to-severe chronic hand eczema.
  • Lebrikizumab showing improvement in post-inflammatory hyperpigmentation in Fitzpatrick IV–VI patients.
  • Nemolizumab approved for AD ≥12 years.
  • Bimekizumab for moderate-to-severe hidradenitis suppurativa.
  • Dupilumab gains indications for chronic spontaneous urticaria and bullous pemphigoid.

These approvals are already shaping updated AD guidelines, which strongly recommend new topicals, biologics, and JAKs for moderate-to-severe disease. Read the full session summary written by Dr. Riyad Seervai to explore the data and subgroup findings.

Jan 23
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Recent Dermatology Drug Approvals: SOCU in the News

By Medical Dermatology

recent dermatology drug approvals

Dermatologists have an increasing number of FDA-approved drugs at their disposal, including therapeutics for patients with skin of color. In an article by the American Journal of Managed Care, Skin of Color Update Conference Co-Chair Andrew F. Alexis, MD, FAAD, gave an update on recent drug approvals in dermatology, including atopic dermatitis (AD), hidradenitis suppurativa, and plaque psoriasis.

The article, which covered Dr. Alexis’s Skin of Color Update session on recent drug approvals, highlighted the approval of tapinarof cream 1% for AD in patients age 2 and older. In the phase 3 ADORING trials, nearly half of treated patients achieved clear or almost clear skin by week 8, with durable, treatment-free intervals observed in longer-term data. Importantly, efficacy and safety were consistent across racial and ethnic subgroups.

Other newly approved topical therapies include roflumilast foam for plaque psoriasis, delgocitinib cream as the first steroid-free topical JAK inhibitor for chronic hand eczema in adults, and ruxolitinib cream for moderate AD in young children, all demonstrating statistically significant improvements versus vehicle and good tolerability, including in diverse patient populations.

The article also covered advances in biologics. Lebrikizumab, an IL-13 inhibitor for moderate-to-severe AD, showed durable skin clearance and improvements in hyperpigmentation. Nemolizumab, targeting the IL-31 receptor, improved skin clearance in AD when combined with topical therapies. For HS, bimekizumab demonstrated sustained efficacy through 48 weeks. Additionally, dupilumab received new approvals for chronic spontaneous urticaria and bullous pemphigoid, marking major progress for conditions with historically limited treatment options.

Dr. Alexis is quoted as saying it was an “extraordinary year” in dermatology. The new therapies are already influencing clinical practice and appearing in clinical guidelines, resulting in meaningful advances for conditions that disproportionately affect patients with skin of color.

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