Third-party issues see FDA slap CRL on lebrikizumab BLA

The US Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema), the drug’s developer, US pharma major Eli Lilly (NYSE: LLY), announced yesterday.

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.

Lilly explained that the letter expressed no concerns about the clinical data package, safety or label for lebrikizumab, and said that none of its other marketed or pipeline products are affected.