LEO Pharma announces U.S. Food and Drug Administration (FDA) acceptance of Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis

LEO Pharma A/S, a global leader in medical dermatology, today announced that the Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been accepted for review by the U.S. Food and Drug Administration (FDA). The acceptance of the BLA is the beginning of the formal review procedure for this potential new treatment by the FDA. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date in the second quarter of 2021.

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 atopic dermatitis.^1,2 The BLA submission is based on data from the pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating the safety and efficacy of tralokinumab.^3,4,5 The safety and efficacy of tralokinumab have not been evaluated by any regulatory authority.

"There is a significant unmet medical need for people whose moderate-to-severe atopic dermatitis remains uncontrolled," said Kim Kjøller, M.D., Executive Vice President, Global Research and Development, LEO Pharma. "If approved, tralokinumab could become the first biologic available to specifically neutralize the IL-13 cytokine and, most importantly, offer a more targeted approach for adults living with this debilitating disease. We will continue to work closely with the FDA as they review this application."

The European Medicines Agency (EMA) recently accepted the marketing authorization application (MAA) for tralokinumab and regulatory review is underway by the Committee for Medicinal Products for Human Use (CHMP).

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About tralokinumab

Tralokinumab is an investigational, fully human, immunoglobulin (Ig) G4 monoclonal antibody (mAb) that works by neutralizing the IL-13 cytokine.¹ IL-13 plays a key role in driving the underlying chronic inflammation in AD.^2,6 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

About the pivotal ECZTRA 1, 2 and ECZTRA 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 safety and efficacy 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 safety and efficacy of tralokinumab (300 mg subcutaneous) in combination with topical corticosteroid (TCS) in adults with moderate-to-severe AD who were 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, including IL-13, play a central role in the key aspects of AD pathophysiology.^2,6

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 Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13R?1 and IL-13R?2. J Mol Biol. 2017;429:208-219.
² Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54?62.
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.

MAT-35840 July 2020