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LEO Pharma Receives Positive CHMP Opinion for New Adtralza (tralokinumab) Injection Device
Details:
Adtralza (tralokinumab), is a pre-filled pen Injection Device with high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis and symptoms.
Adtralza (tralokinumab), is the first and only approved human, monoclonal antibody developed to specifically target and neutralize the IL-13 cytokine, which plays a key role in immune and inflammatory process which are the underlying causes of atopic dermatitis.
Adbry™ (tralokinumab-ldrm) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.
An interim safety analysis from ECZTEND, an open-label, 5-year extension trial, demonstrated consistent safety from the parent trials for up to 3.5 years of Adbry/Adtralza (tralokinumab-ldrm) treatment in adult patients with moderate-to-severe atopic dermatitis.
Adtralza® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine6, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.
Post-hoc analysis from ECZTRA 3 showed improvements in extent and severity of atopic dermatitis, sleep interference, and quality of life in adult patients treated with Adbry (tralokinumab) plus topical corticosteroids as needed over 32 weeks.
3.5-year interim analysis from ECZTEND, an open-label, 5-year extension trial, showed the overall safety profile of tralokinumab-ldrm, inhibit interleukin (IL)-13 cytokine, was consistent with that observed in the parent trials, with no new safety signals.
Adbry can be used with or without TCS. A dosage of 300 mg every four weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.
Tralokinumab met its primary and secondary endpoints, showing that significantly more patients treated with tralokinumab achieved a clinical response, compared to placebo, defined as achieving an IGA 0/1 and/or an EASI 75.
Patients who received continuous treatment with tralokinumab over two years experienced long-term control in atopic dermatitis signs and symptoms, as demonstrated by a median Eczema Area and Severity Index score (EASI) improvement from parent trial baseline of 92.7%.