By Colin Kellaher
The U.S. Food and Drug Administration has turned away Eli Lilly’s application seeking approval of lebrikizumab due to findings that arose during a multi-sponsor inspection of a contract manufacturing organization that included the monoclonal antibody drug substance for the proposed eczema drug.
The Indianapolis drugmaker on Monday said the FDA issued a so-called complete response letter, indicating that it wouldn’t approve the application in its current form.
Eli Lilly said the FDA didn’t flag any concerns about the clinical data package, safety or label for lebrikizumab, adding that none of its other marketed or pipeline products are affected.
Eli Lilly said it plans to work closely with the manufacturer and the FDA to address the agency’s concerns.
Write to Colin Kellaher at [email protected]
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