AstraZeneca Pharmaceuticals LP: anifrolumab

Please refer to your biologics license application (BLA) dated and received (b) (4) for anifrolumab.

This amendment identifies critical data quality issues that affect key analyses, including the primary endpoint, indicating specific deficiencies related to errors in the data submitted at the beginning of the review cycle.

You may submit the correct study data with supporting datasets and corrected labeling for consideration in a new review cycle.