LEO Pharma Announces European Commission Approval of Adtralza ® (tralokinumab) for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents

NOT FOR DISTRIBUTION IN THE UK OR IRELAND

LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Commission (EC) has extended the marketing authorization for Adtralza^® (tralokinumab) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

“Safety is a priority when selecting a treatment option for adolescents living with moderate-to-severe atopic dermatitis, as it can be a chronic and life-long condition,” said Dr. Andreas Wollenberg, dermatologist, allergist, and Professor in the Department of Dermatology and Allergy, Ludwig-Maximilian University of Munich, Germany, and ECZTRA 6 clinical trial investigator. “In the ECZTRA 6 trial, we found the safety and efficacy data of Adtralza to be consistent with adult trials and ongoing long-term safety studies. These findings support the use of this new biologic that specifically targets IL-13 in adolescent patients.”

The approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe AD who were candidates for systemic therapy.³ The approved dose for adolescent patients is an initial dose of 600 mg followed by 300 mg administered every other week, which is the same dosing as for adult patients.²

“Moderate-to-severe atopic dermatitis significantly impacts the lives of adolescents living with the condition, who cope with the discomfort of itch, the challenges of sleep loss and mental health impacts while also navigating this formative period when they transition to adulthood,” said Korey Capozza, MPH, Founder and Executive Director, Global Parents for Eczema Research (GPER). “This group currently faces limited treatment options, and the addition of more options is a positive development for young people living with moderate-to-severe AD.”

The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.

“The European Commission’s approval of Adtralza for use in adolescent patients is a demonstration of our relentless commitment to bringing new treatment options to those living with atopic dermatitis,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S. “Today’s announcement enables us to address the unmet needs of a broader patient population as we look forward to working with key stakeholders across Europe to make Adtralza available to adolescent patients who need it.”

About the ECZTRA 6 Trial

ECZTRA 6 (ECZema TRAlokinumab trial No. 6) is a randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial, with 289 patients aged 12 to 17 (195 Adtralza patients and 94 placebo patients) in the full analysis set, evaluating the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.^3,4

Following a washout period, patients were randomized to subcutaneous Adtralza 150 mg or 300 mg Q2W, or placebo for an initial 16 weeks. Adtralza dosing started with a 300 mg or 600 mg loading dose on day 0 for those receiving Adtralza 150 mg or 300 mg Q2W, respectively.³

At Week 16, patients who responded to Adtralza with an IGA score of 0/1 and/or EASI change of at least 75% from baseline, without use of rescue treatment, were re-randomized to Adtralza Q2W or Q4W for an additional 36 weeks. Patients not achieving primary endpoints at Week 16, those receiving rescue treatment from Week 2 to Week 16, and those meeting other specific criteria were transferred to open-label treatment of Adtralza 300 mg Q2W plus optional mild-to-moderate strength topical corticosteroids.³

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁵ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁶ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.¹

About Adtralza^® (tralokinumab)

Adtralza^® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine⁷, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^1,2 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).^1,7

Adtralza is approved for the treatment of adults and adolescents with moderate-to-severe AD in the European Unionand approved for adults with moderate-to-severe AD in the United States, Great Britain, Canada, the United Arab Emirates, and Switzerland.² Adtralza is marketed in the United States under the tradename Adbry^TM (tralokinumab-ldrm). Applications to extend the indication of Adtralza/Adbry to adolescents are currently under review with several agencies, including the U.S. Food and Drug Administration (FDA).

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.

References

Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54-62 Adtralza® (tralokinumab) EU Product Information. LEO Pharma; October 2022. 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. ClinicalTrialsRegister.eu. Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). Identifier: 2017-005143-33. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46. 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.

MAT-60133 October 2022

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Contact information

David Patti
LEO Pharma, Global Product Communications
+1.973.796.7706
DAPAI@leo-pharma.com