Danish Medicines Council recommends Adtralza® (tralokinumab) as first line biologic treatment option in new treatment guideline for atopic dermatitis

BALLERUP, Denmark, April 27, 2023 – LEO Pharma A/S, a global leader in medical dermatology, welcomes the news that the Danish Medicines Council (DMC) today has published a new treatment guideline for atopic dermatitis (AD).¹ The DMC recommends Adtralza^® (tralokinumab) as a first-line treatment option for moderate-to-severe AD patients aged 12 years and older with inefficient effect from conventional systemic treatments.¹

The assessment of Adtralza is based on data from the pivotal phase 3 trials ECZTRA 1, 2, and ECZTRA 3 as well as the ECZTRA 6 (adolescent trial) and the ECZTRA 7 trial. The treatment guideline recommends biologics, including Adtralza, as the first-line treatment for patients with inefficient effect from conventional systemic treatments.

With the treatment guideline published, Adtralza will now be available as a standard treatment in Denmark for eligible patients.

“We are very pleased to see that the Danish Medicines Council acknowledges Adtralza as a first-line treatment for Danish patients living with atopic dermatitis who are in need of more treatment options. We look forward to helping more patients and physicians fight this debilitating disease,” commented Anja Verhaug, General Manager for LEO Pharma Nordic.

The updated treatment guideline from the Danish Medicines Council, marks the 15^th market where Adtralza is available for treatment of patients with moderate-to-severe atopic dermatitis.

“Presence in LEO Pharma’s home country is an important milestone for us, and we highly welcome the new treatment guideline from the Danish Medicines Council, which enables us to take yet another step in the right direction to make Adtralza available to patients around the world,” said Becki Morison, Executive Vice President, Global Product Strategy and International Operations.

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About Adtralza®  

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

 Adtralza is approved for the treatment of adults and adolescents with moderate-to-severe AD in the European Union, Canada, Great Britain, andUnited Arab Emiratesand is approved for adults with moderate-to-severe AD in the United States, Switzerland and Japan. Adtralza is marketed in the United States under the tradename Adbry® (tralokinumab-ldrm).  

About the pivotal ECZTRA 1, 2, and ECZTRA 3 Trials  
ECZTRA 1 and ECZTRA 2 (ECZemaTRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of Adtralza (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.3  

ECZTRA 3 (ECZemaTRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the safety and efficacy of Adtralza (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.4 

About the ECZTRA 6 trial  

ECZTRA 6 was 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), 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.5 

About the ECZTRA 7 trial 

ECZTRA was a randomized, double-blind, placebo-controlled, parallel-group multicenter 26-weekphase 3 trial, with 277 European adult patients, evaluating the efficacy, safety, and tolerability of tralokinumab (300 mg)administered in combination with topical corticosteroids compared to placeboin adults with severe atopic dermatitiswho were not adequately controlled with or had contraindications to oral cyclosporine A (CSA)6. 

About atopic dermatitis 

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.7 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.8 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.1,2 

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; 429:208-19. 
3. Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437-449. 
4. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐severe atopic dermatitis: results from the double‐blind, randomized, multicentre, placebo‐controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021; 450-463. 
5. ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZemaTRAlokinumab Trial no. 6). Identifier: NCT03526861. https://clinicaltrials.gov/ct2/show/NCT03526861.  
6. ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7. Identifier: NCT03761537. https://clinicaltrials.gov/ct2/show/NCT03761537  
7. Weidinger S, et al. Atopicdermatitis. 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-65440April 2023