Eli Lilly Gets FDA Approval for Eczema Treatment Ebglyss
By Connor Hart
Eli Lilly said the Food and Drug Administration approved its treatment for moderate-to-severe eczema that isn't well controlled despite treatment with topical prescription therapies.
The treatment, called Ebglyss, was approved for adults, as well as children over the age of 12 weighing at least 88 pounds, the Indianapolis pharmaceutical company said Friday.
Ebglyss can be used with or without topical corticosteroids. The treatment is dosed as a monthly maintenance injection after clinical response is achieved, typically occurring after about 16 weeks of biweekly injections.
The treatment was approved for use by the European Commission in 2023, as well as in Japan in January. The company expects approval in additional markets later this year.
The recent approval was based on results of three studies, which included over 1,000 adults and children aged 12 and older with moderate-to-severe eczema.
In an average of two studies, 38% of people who took Ebglyss achieved clear or almost-clear skin at 16 weeks, compared with 12% with placebo, the company said. Additionally, 43% of people who took the treatment felt itch relief at 16 weeks, compared with 12% who took placebo.
"Today's approval allows people the opportunity to reimagine life with eczema as Ebglyss offers a targeted approach to reduce a main cause of eczema inflammation," said Daniel Skovronsky, the company's chief scientific officer and president.
Write to Connor Hart at connor.hart@wsj.com
Corrections & Amplifications
This article was corrected at 5:49 p.m. ET. In an average of two studies, 38% of people who took Ebglyss achieved clear or almost-clear skin at 16 weeks, compared with 12% with placebo, Eli Lilly said. The original version incorrectly said the drug was Ebgylss.
(END) Dow Jones Newswires
September 13, 2024 16:50 ET (20:50 GMT)
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