Janssen Pharmaceuticals, Inc – FDA CRL

Janssen Biotech, Inc. received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) 761433 for amivantamab and hyaluronidase injection, indicating non-approval in its current state. Key issues include deficiencies from a pre-license inspection of the drug product manufacturing facility, necessitating a satisfactory response to FDA Form 483 findings. The company must also submit updated draft prescribing information, ensuring conformance with 21 CFR 201.56 and 201.57 content and format regulations, utilizing the SRPI checklist, and providing it in Structured Product Labeling (SPL) format. Draft carton and container labeling based on prior FDA revisions is also required. Additionally, the previously conditionally acceptable proprietary name needs resubmission after all deficiencies are resolved. A comprehensive safety update, mandated by 21 CFR 314.50(d)(5)(vi)(b), is required, including re-analysis of anti-amivantamab antibodies using an enhanced method and full data evaluation. Janssen must address all identified issues within one year for a complete resubmission, which will trigger a new review cycle and potential re-inspection of the facility.