Pressemeddelelse fra LEO Pharma
- The European Commission regulatory approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, in which Adtralza demonstrated significant improvements in atopic dermatitis signs and symptoms, with treatment response rates gradually improved and maintained over time1-3
- Adtralza was generally well tolerated with an overall frequency and severity of adverse events comparable with placebo1-3
- Adtralza was also shown to reduce itch and improve health-related quality of life1-3
Adtralza will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.1 Adtralza can be used with or without topical corticosteroids (TCS).1
“This European Commission approval of Adtralza means that clinicians across Europe now have an important new treatment option for adult patients with moderate-to-severe atopic dermatitis, which is a chronic, unpredictable skin disease,” said Stephan Weidinger, MD, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Kiel, Germany and tralokinumab clinical trial investigator. “By specifically targeting IL-13 with high affinity, Adtralza has demonstrated that it can reduce atopic dermatitis signs and symptoms and sustain improvements over time.”
The approval is based primarily on efficacy and safety results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included more than 1,900 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-ranging trial, and a vaccine response trial.1
“This European Commission approval of Adtralza is an important development for the millions of adults in Europe who are living with this often uncontrolled skin disease,” said Catherine Mazzacco, President and CEO of LEO Pharma. “We are proud to have the opportunity to offer a new long-term treatment option for moderate-to-severe atopic dermatitis and are working closely with key stakeholders to enable access to Adtralza for eligible patients.”
The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.Additional regulatory filings are underway with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom 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).4,5
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.2
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.3
About atopic dermatitis
Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.6 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.7 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.4
References
Kontakt:
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
Læs hele pressemeddelelsen på Via Ritzau her: https://via.ritzau.dk/pressemeddelelse/leo-pharma-announces-european-commission-approval-of-adtralza-tralokinumab-as-the-first-and-only-treatment-specifically-targeting-il-13-for-adults-with-moderate-to-severe-atopic-dermatitis?releaseId=13624705
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