NOT FOR DISTRIBUTION IN THE UK OR IRELAND
BALLERUP, Denmark-Friday 23 April 2021 [ AETOS Wire ]
The CHMP opinion is primarily supported by data from ECZTRA 1, 2, and 3 trials included in the Marketing Authorization Application
(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 and recommended granting a marketing authorization of Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
The CHMP positive opinion is one of the final steps before the European Commission makes its decision on the Marketing Authorization Application for use of Adtralza, an investigational therapy in clinical development, throughout the European Union. This final decision is expected in the coming months and if authorized, Adtralza will be the first fully human, monoclonal antibody available to specifically target the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. Adtralza specifically targets IL-13 with high affinity and is developed to improve the symptoms of atopic dermatitis, which is a complex and chronic inflammatory skin condition.1,2
“Atopic dermatitis is characterized by its unpredictability, which can be challenging for patients who often experience physical discomfort and emotional effects that may continue for decades,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma. “Today’s CHMP opinion brings LEO Pharma one step closer to the potential of providing Adtralza as a new therapeutic option for EU patients living with moderate-to-severe atopic dermatitis.”
The CHMP opinion is based primarily on data from three pivotal randomized, double-blind, placebo-controlled trials (ECZTRA 1, 2 and ECZTRA 3), which evaluated the safety and efficacy of Adtralza as monotherapy and with concomitant topical corticosteroids (TCS) in more than 1,900 adult patients with moderate-to-severe atopic dermatitis. 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, including the extent and severity of skin lesions, pruritus (itch), sleep and health-related quality of life measures, were measured by changes in the following scores: EASI-90, SCORing Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS), Eczema-Related Sleep NRS and Dermatology Life Quality Index (DLQI). The trials demonstrated that Adtralza met the primary and secondary efficacy endpoints and was generally well tolerated.3,4
Pending the final decision from the European Commission, the marketing authorization will be valid in all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway [with the U.S. Food and Drug Administration (FDA)] and other health authorities worldwide.
About Adtralza (tralokinumab)
Adtralza (tralokinumab) is a fully human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to the IL-13 cytokine with high affinity, thereby preventing interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).1,2
About the pivotal ECZTRA 1, 2, and ECZTRA 3 Trials
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 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 (ECZema TRAlokinumab 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 are candidates for systemic therapy.4
About atopic dermatitis
Atopic dermatitis (AD) 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 a central role in the key aspects of atopic dermatitis pathophysiology.1
About LEO Pharma
LEO Pharma helps people achieve healthy skin. 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 93 million patients in 130 countries. [In 2020, the company generated net sales of DKK 10,133 million]. For more information please visit www.LEO-Pharma.com
References
Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
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.
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.
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.
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.
April 2021 MAT-42443
View source version on businesswire.com: https://www.businesswire.com/news/home/20210423005296/en/
Contacts
Linda Mayer
Global Product Communications
+1 973 908 7924
limay@leo-pharma.com
Henrik Kyndlev
Global External Communications
+45 3140 6180
hdtdk@leo-pharma.com
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