LEO Pharma
LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021
Monday, April 26, 2021 1:00PM IST (7:30AM GMT)
Ballerup, Denmark & Madison, N.J., United States:
Interim analysis at 56 weeks from ECZTEND, an open-label extension trial, demonstrates sustainable and durable efficacy of tralokinumab in adult patients
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Patients enrolled in ECZTRA 1 and 2 parent trials who continued into ECZTEND have now been treated with tralokinumab for two years
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LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.
Provided by Business Wire
Apr 23, 2021 11:59 AM UTC
LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis
NOT FOR DISTRIBUTION IN THE UK OR IRELAND
If authorized, Adtralza® (tralokinumab) will be the first approved biologic that specifically targets the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms1,2
The CHMP opinion is primarily supported by data from ECZTRA 1, 2, and 3 trials included in the Marketing Authorization Application
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.
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Participants included 1,174 patients from ECZTEND at data cut-off.1 Observed outcomes for all patients enrolled 60 weeks prior to data cut-off (n=513) were analyzed at Week 56.1 At parent-trial baseline, ECZTEND baseline, and Week 56, median EASI score was 26.6, 4.7, and 1.8, respectively.1 At Week 56, IGA and EASI response rates were 49.7% (IGA 0/1), 95.1% (EASI-50), 82.8% (EASI-75), 61.0% (EASI-90), and 79.7% (EASI ≤7). An EASI score of ≤7 corresponds to mild atopic dermatitis.1
At the same 56-week data cut-off, measurements of itch and sleep disruptions due to itch were also reported.1 At Week 56, the mean worst weekly pruritus (i.e. itch) numeric rating scale (NRS) score was 3.3 (parent-trial baseline was 7.7) while the mean eczema-related weekly sleep NRS score was 2.0 (parent-trial baseline was 6.9).1