FDA Approves Less Frequent Lebrikizumab Dosing

1

The FDA has approved an every-8-week maintenance dosing regimen for lebrikizumab in patients aged 12 and older with moderate-to-severe atopic dermatitis.
2

Patients achieving an adequate clinical response may receive a 250-mg maintenance dose every 8 weeks or every 4 weeks after initial treatment.
3

The approval was based on longitudinal modeling and clinical data from the Phase 3 ADjoin trial, which evaluated lebrikizumab dosing over 32 weeks.
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No new safety signals were identified in the 32-week extension study, and no patients discontinued treatment due to adverse events.
5

Lebrikizumab selectively targets interleukin-13 and is approved for patients whose atopic dermatitis is not adequately controlled with topical therapies.