FDA CRL - AstraZeneca Pharmaceuticals LP

AstraZeneca Pharmaceuticals LP received a Complete Response Letter from the FDA regarding its Biologics License Application (BLA 761451) for anifrolumab on October 10, 2025. The agency determined it cannot approve the application in its current form due to significant data quality issues found in Study D3465C00001. These errors, identified via a late-cycle amendment, directly impact key analyses and the primary efficacy endpoint. The regulatory framework governing this action includes 21 CFR 601.3(b) and (c), which mandate specific resubmission procedures. To address these deficiencies, AstraZeneca must provide a corrected interim Clinical Study Report, updated electronic datasets (ADaM and SDTM), and the corresponding computer programming files. Additionally, the company must submit a detailed explanation regarding the cause of the database errors and a subject-level log of all data changes. AstraZeneca has one year to resubmit the corrected information or request an extension; otherwise, the FDA may consider the application withdrawn. A formal resubmission must be complete to trigger a new review cycle, and the product cannot be marketed until official approval is granted.