BALLERUP, Denmark–(BUSINESS WIRE)–LEO Pharma A/S, a world 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 Expand the approval of Adtralza ® (tralokinumab) in the European Union (EU) to include adolescents aged 12-17 years 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 given every other week, the same dose 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, United Arab Emirates and Switzerland.2 It is also approved for adults in the United States under the trade name Adbry™. It is not currently approved in any market for use in adolescents.
“Today’s CHMP opinion underscores our confidence in the safety profile and efficacy of Adtralza as we seek regulatory approval to extend its indication to an adolescent patient population,” said said Christophe Bourdon, Managing Director of LEO Pharma A/S. “Treatment options for adolescents in the EU living with moderate to severe atopic dermatitis are limited. Through our clinical efforts, we have strived to ensure that there is sufficient data to support marketing of a new biological option 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 (150mg or 300mg) as monotherapy compared to placebo in adolescents with of moderate to severe AD who were candidates for systemic treatment. Primary endpoints were Investigator’s Global Assessment score for clear or almost clear skin (IGA 0/1) and at least 75% improvement in Area and Severity Index score eczema (EASI-75).3.4
Secondary endpoints were measured by Extent and Severity of Atopic Dermatitis (SCORAD), an improvement of at least 4 points in the adolescent’s weekly mean score on the Worst Numerical Rating Scale daily pruritus (NRS) and the children’s dermatology quality of life index (CDLQI) score.3.4
The positive CHMP 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 in Liechtenstein. Additional regulatory filing is pending with the US Food and Drug Administration (FDA).
About the ECZTRA 6 trial
ECZTRA 6 (ECZema TRAlokinumab trial No. 6) is a multinational, randomized, double-blind, placebo-controlled, parallel-group, 52-week trial, including a total of 301 patients (aged 12-17 years), with 289 ( 195 Adtralza patients and 94 placebo patients) in the entire analysis, evaluating the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy versus placebo in adolescents with moderate atopic dermatitis to severe who were candidates for systemic therapy.3.4
After a washout period, patients were randomized to receive subcutaneous Adtralza 150 mg or 300 mg Q2W, or placebo for an initial period of 16 weeks. Adtralza dosing was started with a loading dose of 300 mg or 600 mg 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 an EASI change of at least 75% from baseline, without the need for rescue therapy, were re-randomised for Adtralza Q2W or Q4W for an additional 36 weeks. Patients not achieving primary endpoints at week 16, those receiving rescue treatment from week 2 through week 16, and those meeting other specific criteria were transferred to open-label treatment at Adtralza 300 mg Q2W plus optional mild to moderate topical corticosteroids.3
About atopic dermatitis
Atopic dermatitis is a chronic inflammatory skin disease characterized by intense itching and eczematous lesions.5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, resulting in chronic inflammation.6 Type 2 cytokines, including IL-13, play an important role in the pathophysiology of atopic dermatitis.seven
About Adtralza® (tralokinumab)
Adtralza® (tralokinumab) is a high affinity human monoclonal antibody developed to bind to and inhibit the cytokine interleukin (IL)-131which plays a role in the immune and inflammatory processes underlying the signs and symptoms of atopic dermatitis.2.7 Adtralza specifically binds to the cytokine IL-13, thereby inhibiting interaction with the α1 and α2 subunits of the IL-13 receptor (IL-13Rα1 and IL-13Rα2).1.7
About LEO Pharma
LEO Pharma is a global company dedicated to improving standards 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 advancing the science of dermatology, and today the company offers a wide range of therapies for all severities of skin disease. sickness. LEO Pharma is headquartered in Denmark and has a global team of 5,800 people, serving millions of patients around the world. In 2021, the company achieved a net turnover of DKK 9,957 million.
Popovic B, et al. Structural characterization reveals the mechanism of the IL-13 neutralizing monoclonal antibody, tralokinumab, as inhibition of IL-13Rα1 and IL-13Rα2 binding. J Mol Biol. 2017; 429:208–19.
Adtralza® (tralokinumab) Product information for the EU. LEO Pharma; June 2021.
Paller A. Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis: results from the phase 3 ECZTRA 6 trial. Fall clinic. Oct. 21-24, 2021. Poster presentation.
ClinicalTrialsRegister.eu. Tralokinumab monotherapy for adolescent subjects with moderate to severe atopic dermatitis – ECZTRA 6 (ECZema TRAlokinumab Trial #6). Identifier: 2017-005143-33.
Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
Boguniewicz M, et al. Atopic dermatitis: a disease characterized by an alteration of the skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.
Bieber T. Interleukin-13: targeting an underappreciated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
MTH-58697 September 2022