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.
2.0 (2.4)
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
Incyte logo. (PRNewsfoto/Eli Lilly and Company)
INDIANAPOLIS, April 23, 2021 /PRNewswire/ Through new analyses of BREEZE-AD5 Phase 3 clinical trial data and an extended safety analysis across multiple trials, Eli Lilly and Company (NYSE: LLY) and Incyte s (NASDAQ:INCY) OLUMIANT
® (baricitinib) 2-mg tablet taken once daily showed improvement in key measured treatment outcomes compared to placebo, and helped further characterize the long-term safety profile in adults with moderate to severe atopic dermatitis (AD). In one BREEZE-AD5 analysis, OLUMIANT provided concurrent improvements in the severity and extent of AD, other key symptoms and quality of life as early as one week, as measured by percent change from baseline compared to placebo. In a separate BREEZE-AD5 analysis, adults with AD on 10-50% of their bodies at baseline who were treated with OLUMIANT showed significant improvements in the severity and extent of disease compared to placebo. In the integrated safety analysis o
LEO Pharma Receives Positive CHMP Opinion of Adtralza (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis
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 symptoms
1,2
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
E-Mail Etrasimod 2 mg treatment group achieved statistical significance in the percentage change in weekly peak pruritis (PP-NRS), in the change in Dermatology Life Quality Index (DLQI), and in the change in Patient-Oriented Eczema Measure (POEM) Etrasimod 2 mg was generally well tolerated, consistent with data in previous trials
Park City, Utah, April 23, 2021 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced data at a late-breaking session at the American Academy of Dermatology VMX Experience. Etrasimod, a novel investigational drug candidate to treat moderate-to-severe atopic dermatitis (AD), demonstrated statistical significance in both clinician and patient reported outcomes in the ADVISE Phase 2b clinical trial. Etrasimod is a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator. Today s results are presented by Emma Guttman-Yassky, MD, PhD, Waldman Professor and Chairwoman, The Kimberly and Eric J. Waldman Department of Derma