Eli Lilly’s Ebglyss (Lebrikizumab-lbkz) Receives the US FDA’s Approval for Treating Moderate-to-Severe Atopic Dermatitis
Shots:
- The US FDA has approved Ebglyss to treat moderate-to-severe AD in adults & children (≥12yrs.) weighing 88 pounds (40kg). Lilly holds its exclusive rights outside the EU, while Almirall has licensed rights in the EU
- The approval was supported by P-III (ADvocate 1 & 2) studies of Ebglyss alone and P-III (ADhere) study of Ebglyss + topical corticosteroids in over 1000 adults & children (12-18yrs.) with mod. to sev. AD
- ADvocate 1 & 2 studies showed clear or almost-clear skin in 38% vs 12% (77% maintained it for 1yr. with QM dosing & 48% maintained it after switching to PBO) and 43% vs 12% had itch relief at 16wks. (85% maintained for 1yr. with QM dosing & 66% maintained it post switching to PBO)
Ref: PRNewswire | Image: Eli Lilly| Press Release
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