Tralokinumab: First Approval

Tralokinumab (Adtralza(R)) is a human IgG4 monoclonal antibody being developed by LEO Pharma for the treatment of atopic dermatitis. The T-helper cytokine IL-13 is thought to play a key role in the pathogenesis of atopic dermatitis. Tralokinumab specifically binds with high affinity to IL-13, inhibiting its interaction with the IL-13 receptor and thereby neutralising the biological activity of the cytokine. Based on results from the ECZTRA 1-3 trials, tralokinumab has recently been approved in the EU for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. This article summarizes the milestones in the development of tralokinumab leading to this first approval for atopic dermatitis.

Automated summary

Tralokinumab, a human IgG4 monoclonal antibody developed by LEO Pharma, has been approved in the EU for the treatment of moderate-to-severe atopic dermatitis. This approval was based on its ability to specifically bind to IL-13 and inhibit its interaction with the IL-13 receptor, neutralizing the cytokine's biological activity.