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LEO Pharma announced today that the U.
This is also the 50th new drug approved by the FDA in 2021
Atopic dermatitis is a chronic inflammatory skin disease characterized by severe itching and eczematous lesions
Adbry is a fully humanized monoclonal antibody that binds to IL-13 with high affinity
▲Adbry (TRAL in the figure) blocks its binding to IL-13Rα1 and IL-13Rα2 by binding to IL-13 (Image source: Reference [2])
The approval of Adbry is based on positive safety and efficacy results from three pivotal Phase 3 trials involving approximately 2,000 adult patients with moderate to severe atopic dermatitis
All 3 pivotal trials met their primary endpoint of EASI 75 for Adbry (300 mg every 2 weeks as monotherapy, or in combination with topical corticosteroids as needed) compared to placebo at Week 16 (Eczema Area and Severity Index improved by 75% or more from baseline), or an IGA score of 0 or 1 (representing complete or near-complete clearance of skin symptoms) was significantly higher
In terms of safety, Adtralza was well tolerated during treatment, with an overall frequency of adverse events comparable to placebo
References:
[1] LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis.
[2] Bieber (2020), Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis.
(Original abridged)
