FDA Declines To Approve Eli Lilly's Eczema Drug

The U.S. Food and Drug Administration (FDA) issued a complete response letter for Eli Lilly And Co's LLY lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema). 

The letter cited findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for Lilly's lebrikizumab.

The letter stated no concerns about the clinical data package, safety, or label for lebrikizumab. No other marketed or pipeline Lilly products are affected. 

Lilly has submitted data to the FDA from ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and adolescents (ages 12 and older) with moderate-to-severe eczema who could not control their symptoms with topical medicines or other systemic treatments.

In May, a new secondary analysis from Eli Lilly's Phase 3 clinical development program showed that patients receiving lebrikizumab who were assessed at 16 weeks experienced up to 73% improved or cleared face or hand dermatitis.

An additional secondary analysis further demonstrated lebrikizumab's stable and long-lasting results at one year of treatment.

Price Action: LLY shares are down 0.77% at $533.00 during the premarket session on the last check Monday.

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