The complete response letter (CRL) from the US regulator did not mention any concerns about the clinical data package, safety or label for lebrikizumab, raising the hope that any delay will not be too long – assuming the issues at the CMO can be resolved or production switched to a new partner.
The CMO is involved in the production of the monoclonal antibody drug substance, according to Lilly, which said no other drugs are affected by the CRL. The company said it will “continue to work closely with the third-party manufacturer and the FDA to address the feedback in order to make lebrikizumab available to patients.”
