Regeneron Pharmaceuticals, Inc. – FDA CRL

Regeneron Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA 761303) for odronextamab, indicating the application cannot be approved in its present form. Key issues identified include deficiencies from a Current Good Manufacturing Practice (CGMP) inspection of a manufacturing facility, requiring satisfactory responses and potentially re-inspection or a pre-license inspection to ensure compliance. The FDA also noted that the submitted prescribing information was not fully responsive to prior communications and did not conform to regulatory content and format requirements, including those specified in 21 CFR 201.56 and 201.57. Specific updates were also requested for carton and container labeling, notably the inclusion of a Medication Guide statement per 21 CFR 208.24(d). While the proprietary name was conditionally acceptable, it requires resubmission after all other deficiencies are resolved. Furthermore, Regeneron must provide a comprehensive safety update, as described in 21 CFR 601.2, detailing all new safety data, adverse events, and worldwide experience. Regeneron is required to fully address all deficiencies and resubmit the BLA within one year.