FDA CRL - Biogen, Inc.

The FDA issued a Complete Response Letter (CRL) to Biogen, Inc. regarding its supplemental new drug application (SNDA) for Spinraza (nusinersen) injection. This SNDA sought approval for a higher dosing regimen, new strength presentations, and updated Prescribing Information (PI) following a clinical study. The FDA could not approve the application due to several deficiencies.

The primary issues involved the proposed Prescribing Information and carton/container labeling, which did not conform to regulatory content and format requirements, specifically 21 CFR 201.56(a), (d), and 201.57. Biogen is required to revise and resubmit these materials, ensuring compliance with established guidelines and submitting the PI in structured product labeling (SPL) format.

Furthermore, a comprehensive safety update is mandated under 21 CFR 314.50(d)(5)(vi)(b). This update must detail any significant safety profile changes, provide new safety data from all studies (including combined analyses and comparisons), present case reports for deaths and serious adverse events, update reasons for trial discontinuations, clarify exposure information, summarize worldwide safety experience, and include English translations of foreign labeling. Minor issues also require attention, such as completing Form 356h with all facility listings and FEI numbers, and clarifying a facility's role in microbiological and sterility testing. Biogen has one year to address these deficiencies and resubmit the application.