Lilly gains FDA approval for lebrikizumab for atopic dermatitis
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- The U.S. FDA has approved Eli Lilly’s Ebglyss (lebrikizumab) for patients 12 years and older suffering from moderate-to-severe atopic dermatitis, also known as eczema.
- The IL-13 inhibitor is given as a 250 mg/2 mL injection and can be used with or without topical corticosteroids.
- After initial dosing at week 0 and week 2, Ebglyss is dosed every two weeks until week 16 or later until adequate clinical response is seen. At this point, the maintenance dosing is a monthly injection.
- Approval was based on the results of several studies that enrolled more than 1,000 adults and children whose eczema symptoms were not adequately controlled with topical prescription medicines.
- The FDA declined to approve lebrikizumab in October 2023 due to issues at a contract manufacturing site.