Regeneron Pharmaceuticals, Inc. – FDA CRL

The FDA issued a Complete Response Letter to Regeneron Pharmaceuticals, Inc. regarding its Biologics License Application for linvoseltamab (Lynozyfic), a treatment submitted under the Public Health Service Act. The agency determined that the application cannot be approved in its current form due to several outstanding issues. The primary obstacle is related to deficiencies identified during a recent inspection of a third-party manufacturing facility. The facility must resolve these findings and provide satisfactory responses to the FDA before the application can proceed. Additionally, the FDA requires Regeneron to update the drug's prescribing information and carton labeling to comply with specific formatting and content standards. To address the remaining concerns, the company must submit a comprehensive safety update that incorporates new data from all clinical and nonclinical trials, including detailed reports on adverse events and trial discontinuations. Other requirements include optimizing quality control methods for assessing product purity and providing additional microbiological data. Regeneron has one year to file a complete resubmission that addresses all identified deficiencies. The product cannot be legally marketed until these issues are resolved and the FDA grants formal approval.