LEO Pharma

LEO Pharma announces European Medicines Agency acceptance of marketing authorization application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis

Share
BALLERUP, Denmark, JUNE 11, 2020 – LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Tralokinumab is a fully human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine which is a key driver of the underlying inflammation in AD.(1,2) The MAA is based on data from the pivotal ECZTRA 1, 2 and 3 Phase 3 studies evaluating the efficacy and safety of tralokinumab.(3,4,5) The efficacy and safety of tralokinumab have not been evaluated by any regulatory authority. 

“People living with atopic dermatitis often face tremendous physical, social and emotional challenges,” said Kim Kjøller, M.D., Executive Vice President, Global Research and Development, LEO Pharma. “Since atopic dermatitis is a heterogeneous disease, we are focused on targeted therapies with the potential to treat individual needs and reduce this burden. We look forward to working closely with the EMA as they review this application.”

 

###

About tralokinumab

Tralokinumab is an investigational, fully human, immunoglobulin (Ig) G4 monoclonal antibody (mAb) that works by neutralizing the IL-13 cytokine.(1,2) IL-13 plays a key role in driving the underlying chronic inflammation in AD.(1,6) By specifically binding to the IL-13 cytokine with high affinity, tralokinumab prevents its interaction with the receptor and the subsequent downstream IL-13 signalling.(1,2)

 

About the pivotal ECZTRA 1, 2 and 3 Phase 3 studies

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 patients, respectively, to evaluate the efficacy and safety of tralokinumab (300 mg subcutaneous) as monotherapy in adults with moderate-to-severe AD who were candidates for systemic therapy.(3,4)

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week study, which included 380 patients, to evaluate the efficacy and safety of tralokinumab (300 mg subcutaneous) in combination with topical corticosteroid (TCS) in adults with moderate-to-severe AD who are candidates for systemic therapy.(5)

About atopic dermatitis
Atopic dermatitis (AD) is a chronic, inflammatory, heterogeneous skin disease characterized by intense itch and eczematous lesions.(7) AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.(8) Type-2 cytokines, such as IL-13 and IL-4, play a central role in the key aspects of AD pathophysiology.(1)

 

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;429:208-219.

3.ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) (ECZTRA 1). Identifier NCT03131648. https://clinicaltrials.gov/ct2/show/NCT03131648

4. ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2) (ECZTRA 2). Identifier NCT03160885. https://www.clinicaltrials.gov/ct2/show/NCT03160885

5. ClinicalTrials.gov. National Library of Medicine (U.S.).  Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 (ECZema TRAlokinumab Trial no. 3). Identifier NCT03363854. https://clinicaltrials.gov/ct2/show/study/NCT03363854

6. Tsoi LC, et al. Atopic dermatitis is an IL-13 dominant disease with greater molecular heterogeneity compared to psoriasis. J Invest Dermatol 2019;139:1480-1489.

7. Weidinger S, et al. Atopic dermatitis. 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.

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

About LEO Pharma

LEO Pharma
LEO Pharma
Industriparken 55
2750 Ballerup

4494 5888http://www.leo-pharma.com/

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 92 million patients in 130 countries. For more information about LEO Pharma, 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 phase 3 head-to-head data results from DELTA FORCE trial comparing delgocitinib cream with alitretinoin capsules in adults with severe chronic hand eczema (CHE)24.1.2024 08:00:00 CET | Pressemeddelelse

Delgocitinib cream demonstrated a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules as its primary outcome measure. Delgocitinib cream also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, health-related quality of life (HRQoL), and a lower number of treatment-emergent adverse events. DELTA FORCE is the first head-to-head phase 3 trial comparing a systemic and topical treatment for CHE.1 With only one treatment option currently approved for severe CHE and no approved optionsfor more moderate forms of the disease, there is a considerable unmet need for patients living with CHE.

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.

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
HiddenA line styled icon from Orion Icon Library.Eye