BALLERUP, Denmark - Saturday, 17. September 2022 AETOSWire
Positive CHMP opinion recommends extending use of Adtralza® (tralokinumab) to adolescents (12-17 years old) in the European Union (EU)
Recommendation supported by data from the Phase 3 ECZTRA 6 trial
(BUSINESS WIRE) -- LEO Pharma A/S, a global leader in medical dermatology, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending to extend the approval of Adtralza® (tralokinumab) in the European Union (EU) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The recommended 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.
Adtralza, a high-affinity human monoclonal antibody,1 is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland.2 It also is approved for adults in the United States under the tradename Adbry™. It is not currently approved in any market for adolescent use.
“Today’s CHMP opinion underscores our confidence in the safety profile and effectiveness of Adtralza as we seek to obtain regulatory approval to expand its indication for use in an adolescent patient population,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S. “There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis. Through our clinical efforts, we have worked to ensure there is sufficient data to support bringing a new biologic option to market for these patients.”
The CHMP opinion 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. Primary endpoints were the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).3,4
Secondary endpoints were measured by extent and severity of atopic dermatitis (SCORAD), at least a 4-point improvement in adolescent weekly average Worst Daily Pruritus Numeric Rating Scale (NRS) score, and Children’s Dermatology Life Quality Index (CDLQI) score.3,4
The CHMP’s positive opinion will be reviewed by the European Commission (EC) and pending the final decision, the marketing authorization will be valid in all EU Member States, Iceland, Norway, and Liechtenstein. An additional regulatory filing is underway with the U.S. Food and Drug Administration (FDA).
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, including a total of 301 patients (aged 12 to 17), with 289 (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 atopic dermatitis pathophysiology.7
About Adtralza® (tralokinumab)
Adtralza® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine1, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.2,7 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
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.
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.
Adtralza® (tralokinumab) EU Product Information. LEO Pharma; June 2021.
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.
Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
MAT-58697 September 2022
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LEO Pharma, Global Product Communications