EU approves first IL-13 antibody therapy for atopic dermatitis

Today, LEO Pharma announced that the European Commission has approved the marketing of Adtralza (tralokinumab) for the treatment of moderate to severe atopic dermatitis patients receiving systemic therapy

Atopic dermatitis is a chronic inflammatory skin disease.

Atopic dermatitis is caused by skin barrier dysfunction and immune disorders.

▲IL-13 is highly expressed in a variety of different cell types in the skin of patients with atopic dermatitis (picture source: reference [4])

Based on the important role of type 2 cytokines in inflammatory diseases, a variety of approved and researched therapies target the targets of type 2 cytokines or downstream signaling pathways

▲Adtralza (TRAL in the picture) binds to IL-13 to block its binding to IL-13Rα1 and IL-13Rα2 (picture source: reference [4])

This approval is based on the efficacy and safety results of 3 pivotal Phase 3 clinical trials, involving more than 1,900 adult patients with moderate to severe atopic dermatitis

The results of the trial showed that Adtralza was used as a monotherapy in two clinical trials and reached the primary endpoint of the trial after 16 weeks of treatment.

In terms of safety, Adtralza was well tolerated during treatment for up to 52 weeks

Currently, Lilly also has a monoclonal antibody therapy targeting IL-13, lebrikizumab, in phase 3 clinical development

In addition, Pfizer's JAK1 inhibitor abrocitinib and AbbVie's JAK inhibitor Rinvoq also reached the primary endpoint in a phase 3 clinical trial for the treatment of atopic dermatitis

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Reference materials:

[1] LEO Pharma announces European Commission approval of Adtralza® (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis.

[2] AstraZeneca enters licensing agreements with LEO Pharma in skin diseases.

[3] Lilly and Dermira Present New Lebrikizumab Phase 2b Clinical Data Showing Patients with Atopic Dermatitis Had Clinically Meaningful Improvements in Itch, Sleep and Quality of Life.

[4] Bieber (2020), Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis.

[5] Wollenberg, et al.