European Commission approves Ebglyss for adults, adolescents with atopic dermatitis

Key takeaways:

• Ebglyss (lebrikizumab) is a monoclonal antibody that inhibits IL-13 for the treatment of atopic dermatitis.
• The approval of Ebglyss was supported by positive results from three phase 3 trials.

The European Commission has approved Ebglyss in the European Union for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older, Almirall announced in a press release.

“The [European Commission] approval of lebrikizumab for people suffering with moderate to severe AD provides another much-needed treatment option for this challenging disease,” Volker Koscielny, chief medical officer of Almirall, said in the release. “We are confident that due to its demonstrated short- and long-term efficacy, with monthly maintenance dosing and a consistent safety profile, it has the potential to become a first-line biologic treatment.”

The approval of Ebglyss (lebrikizumab), a monoclonal antibody that inhibits IL-13 signaling, was supported by three pivotal phase 3 studies: ADvocate 1, ADvocate 2 and ADhere.

ADvocate 1 and 2 evaluated Ebglyss as a monotherapy, finding that the drug reduced AD extent and severity by 75% or more in almost six out of 10 patients by week 16. In ADhere, which assessed Ebglyss in combination with topical corticosteroids, almost seven out of 10 patients achieved this reduction.

Also, almost 80% of week 16 responders across all studies continued treatment with Ebglyss and sustained skin clearance for up to 2 years.

The majority of adverse events were mild to moderate in severity and included conjunctivitis, injection site reactions, allergic conjunctivitis and dry eye.

According to the press release, Almirall will begin its Ebglyss commercial launch in Germany before rolling out to more European countries through 2024.