Eli Lilly has resubmitted its Biologics License Application (BLA) for Lebrikizumab for the treatment of moderate to severe atopic dermatitis (AD), with regulatory action anticipated in the second half of 2024.

The Company announced  the news along with its financial results for the first quarter of 2024 during a live webcast.

Lebrikizumab is subcutaneous recombinant humanized IgG4 anti-IL-13 monoclonal antibody. Almirall has the licensed rights to develop and commercialize lebrikizumab in Europe, while Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and the rest of the world.

Lebrikizumab Timeline

October 2023

The U.S. Food and Drug Administration issued a complete response letter (CLR) to Eli Lilly for its BLA of lebrikizumab, citing findings uncovered during an inspection of a third-party contract manufacturing organization. There were no concerns with lebrikizumab’s clinical data package, safety, or label.

November 2023

Lebrikizumab (Ebglyss, Almirall) was approved by the European Commission for the treatment of atopic dermatitis, and Germany became the first country where lebrikizumab was available as a prescription.

April 2024

Eli Lilly resubmits BLA for lebrikizumab.