European Medicines Agency recommends Ebglyss for atopic dermatitis treatment
Click Here to Manage Email Alerts
Key takeaways:
- Ebglyss is an investigational interleukin-13 inhibitor.
- Positive opinion is based on the company’s phase 3 clinical development program.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the marketing authorization of Ebglyss for atopic dermatitis in patients aged 12 years and older, according to an Almirall press release.
The European Commission is now reviewing the committee’s recommendation of Ebglyss (lebrikizumab), an investigational interleukin-13 inhibitor, for the treatment of moderate to severe AD. According to the release, the company expects the biologic to be approved in the European Union within 2 months which will be followed shortly by the product’s launch.
"The positive [Committee for Medicinal Products for Human Use] recommendation for Ebglyss in moderate to severe AD represents a significant milestone in bringing a next-generation biologic therapy to people living with atopic dermatitis, providing a much-needed additional treatment option,” Karl Ziegelbauer, PhD, chief scientific officer at Almirall, said in the release.
The committee’s opinion is based on Almirall’s phase 3 clinical development program comprised of ADvocate 1, ADvocate 2 and ADhere.
In the first two studies, more than 50% of patients treated with lebrikizumab monotherapy achieved at least a 75% reduction in disease severity by week 16. In ADhere, almost 70% of patients also showed a 75% reduction in disease severity when combining lebrikizumab with topical corticosteroids.
The trials also found that lebrikizumab is safe to use with the most common adverse reactions being mild to moderate in severity.
While Eli Lilly and Company has exclusive rights to develop and commercialize lebrikizumab in the United States, Almirall has licensed the rights for the drug in Europe. The company is currently awaiting regulatory decisions on expanding the product’s reach to additional European markets including the United Kingdom and Switzerland in 2024.