LEO Pharma receives positive CHMP opinion of Adtralza® (tralokinumab) for the treatment of adults with moderate-to-severe atopic dermatitis
BALLERUP, Denmark, 23 APRIL, 2021 – 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.”
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
- 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
Global Product Communications
+1 973 908 7924
Global External Communications
+45 3140 6180
About LEO Pharma
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
Subscribe to releases from LEO Pharma
Subscribe to all the latest releases from LEO Pharma by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from LEO Pharma
LEO Pharma announces positive outcome of DELTA 3 open-label extension trial of delgocitinib cream in the treatment of adults with moderate to severe chronic hand eczema (CHE)30.10.2023 10:00:00 CET | Pressemeddelelse
Subjects who completed the 16-week twice-daily treatment regimen of delgocitinib cream or cream vehicle in the phase 3 DELTA 1 or DELTA 2 trials were offered to immediately enroll into the 36-week DELTA 3 extension trial.1 The DELTA 3 trial evaluated the long-term safety of twice-daily as needed treatment with delgocitinib cream for up to 36 weeks in adults with moderate to severe CHE.1 The long-term safety profile of delgocitinib cream was consistent with previous results from the DELTA 1 and 2 trials. Patients who entered the DELTA 3 trial after receiving delgocitinib cream in the DELTA 1 and DELTA 2 trials maintained similar levels of symptom relief and treatment success over an additional 36-week treatment regimen.
LEO Pharma provides update on the development program for izuforant20.10.2023 09:43:02 CEST | Pressemeddelelse
The Phase 2a/b international trial to evaluate the efficacy and safety of orally administered izuforant tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe AD did not meet the primary endpoint. As a result, LEO Pharma ends the program for izuforant and terminates the license agreement with JW Pharmaceutical. LEO Pharma remains committed to delivering value for patients living with atopic dermatitis and other skin diseases.
LEO Pharma Presents New Long-Term Data on Use of Adtralza® (tralokinumab) to Treat Moderate-to-Severe Atopic Dermatitis (AD)13.10.2023 10:35:00 CEST | Pressemeddelelse
A post hoc four-year interim subgroup analysis of the ongoing ECZTEND open-label extension trial assessed whether continuous use of Adtralza provided long-term disease control in adult patients with moderate-to-severe AD.1 Evidence of a safety profile consistent with previous study results for Adtralza was further supported by both the above interim ECZTEND results and an integrated analysis of the ECZTEND trial plus seven of the parent trials.1,2 Initial findings from the cohort study of patients with atopic dermatitis to evaluate tralokinumab real-world clinical use (TRACE).3
LEO Pharma Presents Phase 3 Results of Delgocitinib Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE) at EADV 202313.10.2023 10:35:00 CEST | Pressemeddelelse
Phase 3 DELTA 2 results demonstrated that delgocitinib cream provided statistically significant improvements in both patient- and clinician-reported efficacy outcomes compared to cream vehicle, building on the data from the identically designed DELTA 1 trial.1,2 Additional analysis from the DELTA 2 trial concluded that twice-daily application of delgocitinib cream resulted in minimal systemic exposure, further supporting its safety profile.3
LEO Pharma to Reveal New Findings in Moderate to Severe Atopic Dermatitis (AD) and Chronic Hand Eczema (CHE) at the 2023 EADV Congress12.10.2023 11:00:00 CEST | Pressemeddelelse
New Adtralza® (tralokinumab) data examines the long-term safety and efficacy of the drug for the treatment of moderate to severe AD, as well as its real-world clinical positioning.1,2,3 Delgocitinib cream presentations include new data from the DELTA 2 clinical trials, which assessed the safety and efficacy of the topical treatment for moderate to severe CHE.4,5 Phase 2a trial results assessing the efficacy and safety of temtokibart (LEO 138559), LEO Pharma's IL-22RA1 antibody, will also be presented at the conference.6
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom