The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorisation of LEO Pharma’s tralokinumab. The treatment is for moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) will consider the positive recommendation from the CHMP and deliver its final decision on the Marketing Authorisation Application (MAA) for the UK in line with European Commission approval. These final decisions are expected in the coming months and if authorised, tralokinumab will be the first fully human, monoclonal antibody available to specifically target the IL-13 cytokine only, a key driver of atopic dermatitis signs and symptoms.1,2 Tralokinumab specifically targets IL-13 with high affinity and is developed to improve the symptoms of atopic dermatitis, which is a complex and chronic inflammatory skin condition.1,2
Pending the final decision from the European Commission (EC), the centralised marketing authorisation will be valid in Ireland and all other EU Member States, Iceland, Norway, Liechtenstein and Northern Ireland. Following new regulatory process due to the departure of the UK from the EU, the MHRA will consider the positive recommendation from the CHMP and will deliver its final decision on the MAA for the UK in line with EC approval. Additional regulatory filings are underway [with the U.S. Food and Drug Administration (FDA)] and other health authorities worldwide.
Dr Andrew Pink, Consultant Dermatologist and Honorary Clinical Lecturer at St. John’s Institute of Dermatology, Guy’s & St. Thomas’ NHS Foundation Trust, London said: “Atopic dermatitis is characterised by its unpredictability, which can be challenging for patients who often experience both physical discomfort and the emotional effects of the disease. New treatment options are needed to better support people living with the condition.”
Professor Alan Irvine, Professor of Dermatology, Trinity College Dublin said: “IL-13 is a key driver of the underlying chronic inflammation in atopic dermatitis, having more available targeted treatment options provides clinicians with greater choice to better support atopic dermatitis patients and their often complex needs.”
Amit Aggarwal, Medical Director, LEO Pharma UK and Ireland said: “LEO Pharma has a rich heritage in medical dermatology. We have spent decades researching skin conditions placing us in a unique position to understand patient needs. Today’s CHMP opinion brings LEO Pharma one step closer to the potential of providing tralokinumab as a much needed new therapeutic option for patients living with moderate-to-severe atopic dermatitis in the UK and Ireland.”
 Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
 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.