FDA CRL - Bioverativ USA Inc

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Bioverativ USA, Inc. for its Biologics License Application (BLA) 761164 for sutimlimab. The FDA determined the application could not be approved in its present form due to several unaddressed issues. A key concern involves deficiencies identified during a recent inspection of a manufacturing facility, requiring satisfactory resolution. Additionally, the regulatory framework necessitates revisions to the proposed prescribing information, which must be updated in structured product labeling (SPL) format. Draft carton and container labeling, incorporating FDA's proposed revisions, must be submitted, along with a specific Medication Guide statement on the labels. The company also needs to resubmit the proposed proprietary name, Enjaymo. Critically, a comprehensive safety update is required, encompassing new nonclinical and clinical data, detailed safety profile changes, combined adverse event tabulations, retabulated trial discontinuations, and narrative summaries for deaths and serious adverse events. This update must also include updated exposure information, a worldwide safety summary, and English translations of any foreign labeling. Bioverativ USA, Inc. must fully address all deficiencies and resubmit the application within one year. The product cannot be legally marketed until written approval is granted.