MHRA approves Adtralza®▼(tralokinumab) for the treatment of adolescent patients with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy
- The Medicines and Healthcare products Regulatory Agency (MHRA) have approved tralokinumab for the treatment of adolescent patients aged 12 to 17 with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy, following the European Commission (EC) approval in September.1,2
- The EC and MHRA approvals are supported by data from the Phase 3 ECZTRA 6 trial.3,4
Hurley, Berks, United Kingdom, 25 November, 2022 – LEO Pharma announced that both the European Commission (EC) and the Medicines and Healthcare products Regulatory Agency in the United Kingdom (MHRA) have now approved to extend the terms of the marketing authorisation for tralokinumab to include the treatment of adolescents aged 12 years and older.1,2
The EC approved the change to the terms of the marketing authorisation on the 14th October 2022.2 The MHRA has now also granted approval for the United Kingdom on 4th November 2022.1
Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis who are candidates for systemic therapy.5,6,7 The recommended dose for adolescent patients is an initial dose of 600 mg followed by 300mg administered every other week, which is the same dosing for adult patients.1,2
Research has shown that moderate-to-severe atopic dermatitis can take a physical, psychosocial, and emotional toll on adolescent patients, and there is a significant unmet need to help patients gain control of their disease through well-tolerated and effective treatments.8,9 Approximately 6% of adolescents aged 12 to 17 years have atopic dermatitis in the United Kingdom.10
“We are pleased that adolescents between 12-17 years of age living with atopic dermatitis will now have more treatment options available to them. LEO Pharma is committed to working with regulatory authorities to make tralokinumab available to all patients who need it.” said Sarah Kleinpeter, Vice President and General Manager of United Kingdom and Ireland at LEO Pharma.
“Atopic dermatitis is an underestimated condition that has a significant impact on a young person’s quality of life. The extended approval of tralokinumab for the treatment of adolescents with atopic dermatitis is an important development, giving Dermatologists more treatment options for this group of patients.” Dr James Halpern, Consultant Dermatologist for Dermatology at Walsall Healthcare NHS Trust.
The EC decisions are valid for all European Union Member States, including Ireland and Northern Ireland, as well as Iceland, Norway, and Liechtenstein.2
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals and patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or to the manufacturer.
1. Adtralza ® (Tralokinumab) Summary of Product Characteristics. Medicines & Healthcare products Regulatory Agency; November 2022.
2. Adtralza® (Tralokinumab) Human medicine European public assessment report. European Medicines Agency; November 2022.
3. Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial. Fall Clinical. Oct. 21-24, 2021. Poster Presentation.
4. ClinicalTrialsRegister.eu. Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). Identifier: LP0162- 1334.
5. Duggan, S. Tralokinumab: First Approval. Drugs. 2021;81:1657–1663.
6. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429:208–19.
7. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54-62.
8. Na CH, et al. Quality of Life and Disease Impact of Atopic Dermatitis and Psoriasis on Children and Their Families. Children (Basel). 2019; 6(12):133:1-4.
9. Cork, M.J., Danby, S.G. and Ogg, G.S. Atopic dermatitis epidemiology and unmet need in the United Kingdom. J Dermatolog Treat. 020;31(8):801-809.
10. de Lusignan, S, Alexander, H, Broderick, C, et al. The epidemiology of eczema in children and adults in England: A population-based study using primary care data. Clin Exp Allergy. 2021; 51: 471– 482.
11. AdbryTM (tralokinumab) DRUGS@FDA: FDA-approved drugs. FDA; December 2021.
12. Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis Primers. 2018 Jun 21;4(1):1.
13. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.