FDA approves efficacy supplement for Amgen's Repatha

The FDA has approved an efficacy supplement for Repatha, the cholesterol-lowering drug marketed by Amgen. The application, BLA125522, submission number 47, was approved with a status date of October 9, 2026.¹

The filing is classified by the FDA as an efficacy submission with standard review priority, according to the agency's drug database. Repatha is formulated as an injectable product with the active ingredient evolocumab at a strength of 140MG/ML, administered by injection.¹

The sponsor of record for the application is Amgen Inc, as listed in the FDA database entry. The submission type is designated SUPPL (supplement), with submission class "Efficacy," and the approval status is recorded as "AP."¹

No additional details about the specific clinical data, labeling changes, or indication expansion tied to this supplement are included in the available FDA record. Readers seeking the underlying rationale for the efficacy supplement should consult the full FDA application file for BLA125522, as the summary record does not specify what efficacy data or label modifications prompted the submission.