Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved its targeted IL-13 inhibitor Ebglyss (lebrikizumab-lbkz) to treat moderate-to-severe atopic dermatitis (AD).

The drug has been authorised for use in adults and adolescents aged 12 years and older with a body weight of at least 40kg and whose AD is not well controlled despite treatment with topical prescription therapies.

Typically referred to as eczema, AD is an inflammatory condition that causes the skin to become itchy, dry and cracked. It occurs in 7.3% of adults in the US, and of those affected, about 40% have moderate or severe symptoms.

Ebglyss can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection following an initial treatment phase.

The FDA’s decision was supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy, as well as data from the phase 3 ADhere study assessing the drug in combination with topical corticosteroids.

At week 16, 38% of patients being treated with Ebglyss in ADvocate 1 and 2 achieved clear or almost-clear skin, compared to 12% of those receiving placebo, and 10% of Ebglyss-treated patients saw these results from as early as week four. Of the patients who experienced clear or almost-clear skin at week 16, 77% maintained those results at one year with once-monthly dosing.

Daniel Skovronsky, chief scientific officer and president of Lilly Research Laboratories, and president, Lilly Immunology, said: “[This] approval allows people the opportunity to reimagine life with eczema as Ebglyss offers a targeted approach to reduce a main cause of eczema inflammation.”

Lilly has exclusive rights for development and commercialisation of Ebglyss in the US and the rest of the world outside Europe, where Almirall has licenced the rights to develop and commercialise the drug as a treatment for dermatology indications.