Eli Lilly And Company – FDA CRL

The FDA issued a Complete Response Letter to Eli Lilly and Company for its Biologics License Application (BLA 761248) for Kisunla (LY3002813) injection, indicating the application cannot be approved in its present form. The primary deficiency, cited under section 351(a) of the Public Health Service Act, is an insufficient safety database to adequately characterize the long-term safety of Kisunla in treating Alzheimer’s disease. The FDA expected data from at least 100 patients exposed to the highest proposed dosage regimen for 12 months, consistent with ICH E1 guidelines; however, the submission included only 49 such patients. The agency emphasized that long-term safety must be based on continuous exposure at the highest dosage.

To address this, Eli Lilly must provide comprehensive long-term safety data, likely requiring unblinded controlled safety data from Study AACI once completed. A detailed safety update is mandated, encompassing changes in the safety profile, new and combined adverse event data, updated exposure information, and a thorough analysis of Amyloid-Related Imaging Abnormalities (ARIA). Additionally, the company needs to revise the prescribing information to conform to prior communications and regulatory standards, submitting it in structured product labeling (SPL) format. The proprietary name, Kisunla, must also be resubmitted with the response to these deficiencies.