Eli Lilly and Company: lebrikizumab

RRA and conducted a pre-license inspection (PLI) to further evaluate the facility.

Your complete response should include the date of the facility's response to the FDA Form 483. The assessment of the application approvability and resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include a re-inspection of the facility.

If any impacted data are removed from the application and/or changes are made to the control strategy to address the facility deficiencies, provide additional information and data (e.g., testing results from repeated studies) that are reliable and accurate to support that consistent process performance and product quality is achieved.

Indiana (FEI 1819470), manufacturing facility listed in this application, FDA conveyed deficiencies to the representative of the facility.

Service Act for Kisunla (LY3002813) injection.

Kisunla in the treatment of Alzheimer's disease.

We acknowledge that you have tried to meet the exposure requirements through a "treatment protocol" approach based on the dosage regimen of Kisunla specified in the protocol, in which the Kisunla dose was either reduced or stopped when amyloid beta plaque measurements declined to a pre-specified threshold on PET imaging.

A future resubmission intended to adequately characterize the long-term safety of Kisunla would likely need to include the unblinded controlled safety data from Study AACI, once it is completed, as we are not aware of other extant or pending safety data that have the potential to adequately characterize the long-term safety of Kisunla.

Also provide an accounting of the number of subjects who switched to placebo based on amyloid plaque reduction at Weeks 24, 52, 76, 102, and 130.

BLA 761215 seeks licensure of Rezvoglar (insulin glargine-aglr) as an interchangeable biosimilar with U.S.-licensed Lantus.

The subject of this action letter is BLA 761215/Original2. A separate action letter was issued for BLA 761215/Original 1.

We have completed our review of BLA 761215/Original 2, as amended, and have determined that we cannot approve this application in its present form.