Eli Lilly’s drug lebrikizumab has been approved for the treatment of eczema, or atopic dermatitis, a win for the company after the FDA rejected the drug last year over issues with a contract manufacturer.
The medicine will be sold as Ebglyss and was approved by the FDA on Friday as an injectable treatment for adults and children 12 years and older who have moderate-to-severe eczema that hasn’t been well-controlled despite treatment with topical drugs.
According to Lilly, the drug will be available in the “coming weeks.” Ebglyss was already approved in the EU last year and in Japan earlier this year. The company declined to comment on the price of the treatment.
Ebglyss is a targeted IL-13 inhibitor, and is given once a month following an initial 16 weeks of every-other-week dosing.
“We now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough,” Jonathan Silverberg, a professor of dermatology at George Washington University who worked on the research supporting the drug, said in a Lilly-provided statement.
Lilly received a complete response letter from the FDA in October last year after issues were found at a third-party manufacturer, though the agency didn’t raise concerns with safety or labeling.
The agency based its approval of the treatment on the ADvocate 1, ADvocate 2 and ADhere studies, which evaluated skin clearance after 16 weeks. Between ADvocate 1 and 2, 38% of patients on Lilly’s drug achieved clear or almost-clear skin at 16 weeks compared with 12% of patients on placebo. Of the people who experienced clear or almost-clear skin at week 16, 77% maintained clear or almost-clear skin at one year with the once-a-month dose.
The most common side effects of the drug were eye and eyelid inflammation, injection site reactions and shingles.