Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older
Shots:
- The EMA has accepted a submission to extend marketing authorization of Ebglyss (lebrikizumab) to pts (6mos. to <18yrs., weighing <40kg) with mod. to sev. atopic dermatitis
- Application was supported by interim data from the pediatric clinical program, incl. the ADorable-1 evaluating Ebglyss in pts (6mos. to <18yrs.), & the ADorable-2 LTE study assessing safety & efficacy during maintenance treatment
- In ADorable-1, Ebglyss met both co-primary and key 2EPs vs PBO, delivering meaningful improvements in skin clearance, disease severity, itch, and quality of life, with a consistent safety profile
Ref: Businesswire | Image: Almirall | Press Release
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