LEO Pharma Announces European Medicines Agency Acceptance of Marketing Authorization Application for tralokinumab for the Treatment of Adults With Moderate-To-Severe Atopic Dermatitis

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Tralokinumab is a fully human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine which is a key driver of the underlying inflammation in AD.^1,2 The MAA is based on data from the pivotal ECZTRA 1, 2 and 3 Phase 3 studies evaluating the efficacy and safety of tralokinumab.^3,4,5 The efficacy and safety of tralokinumab have not been evaluated by any regulatory authority.

“People living with atopic dermatitis often face tremendous physical, social and emotional challenges,” said Kim Kjøller, M.D., Executive Vice President, Global Research and Development, LEO Pharma. “Since atopic dermatitis is a heterogeneous disease, we are focused on targeted therapies with the potential to treat individual needs and reduce this burden. We look forward to working closely with the EMA as they review this application.”

###

About tralokinumab
Tralokinumab is an investigational, fully human, immunoglobulin (Ig) G4 monoclonal antibody (mAb) that works by neutralizing the IL-13 cytokine.^1,2 IL-13 plays a key role in driving the underlying chronic inflammation in AD.^1,6 By specifically binding to the IL-13 cytokine with high affinity, tralokinumab prevents its interaction with the receptor and the subsequent downstream IL-13 signalling.^1,2

About the pivotal ECZTRA 1, 2 and 3 Phase 3 studies
ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational, 52-week trials, which included 802 and 794 patients, respectively, to evaluate the efficacy and safety of tralokinumab (300 mg subcutaneous) as monotherapy in adults with moderate-to-severe AD who were candidates for systemic therapy.^3,4

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week study, which included 380 patients, to evaluate the efficacy and safety of tralokinumab (300 mg subcutaneous) in combination with topical corticosteroid (TCS) in adults with moderate-to-severe AD who are candidates for systemic therapy.⁵

About atopic dermatitis
Atopic dermatitis (AD) is a chronic, inflammatory, heterogeneous skin disease characterized by intense itch and eczematous lesions.⁷ AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁸ Type-2 cytokines, such as IL-13 and IL-4, play a central role in the key aspects of AD pathophysiology.¹

About LEO Pharma
The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. For more information about LEO Pharma, visit www.leo-pharma.com.

References
¹ Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54–62.
² 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;429:208-219.
³ ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) (ECZTRA 1). Identifier NCT03131648. https://clinicaltrials.gov/ct2/show/NCT03131648
⁴ ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2) (ECZTRA 2). Identifier NCT03160885. https://www.clinicaltrials.gov/ct2/show/NCT03160885
⁵ ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 (ECZema TRAlokinumab Trial no. 3). Identifier NCT03363854. https://clinicaltrials.gov/ct2/show/study/NCT03363854
⁶ Tsoi LC, et al. Atopic dermatitis is an IL-13 dominant disease with greater molecular heterogeneity compared to psoriasis. J Invest Dermatol 2019;139:1480-1489.
⁷ Weidinger S, et al. Atopic dermatitis. Lancet 2016;387:1109-1122.
⁸ Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.