FDA Approval of Lebrikizumab: A New Hope for Moderate to Severe Atopic Dermatitis

FDA Approves Lebrikizumab for Atopic Dermatitis

The FDA approved lebrikizumab (Ebglyss; Eli Lilly) on Friday to treat patients aged 12 and older with moderate to severe atopic dermatitis (AD) who weigh at least 88 pounds.

This approval provides patients with a new first-line biologic treatment and specifically targets those whose disease is not well controlled with topical therapies. More specifically, lebrikizumab is an interleukin (IL)-13 inhibitor, preventing the skin from becoming spongiotic, therefore stopping significant itching.

Dosing and Administration

• Lebrikizumab 250 mg/2 mL injection can be used with or without topical corticosteroids (TCS).
• The recommended initial starting dose is 500 mg, equating to 2 250-mg injections at weeks 0 and 2.
• Follow-up with 250 mg every 2 weeks until week 16 or longer, as necessary, based on clinical response.
• After achieving adequate clinical response, maintenance dosing is a single monthly injection or 250 mg every 4 weeks.

Lilly announced that lebrikizumab will be available to US patients in the coming weeks and is working with insurers, health systems, and providers to enable broad patient access. Lebrikizumab was previously approved for use by the European Commission in 2023 and Japan in January 2024; Lilly said it expects the treatment to be approved by additional markets later this year.

Impact on Eczema Management

Today’s approval allows individuals the opportunity to reimagine life with eczema as Ebglyss offers a targeted approach to reduce a main cause of eczema inflammation.