FDA BLA · BLA125522

REPATHA

evolocumab

Sponsor: AMGEN INC

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APPLICATION
BLA125522
TYPE
BLA
ORIGINAL APPROVAL
2015-08-27
LATEST ACTION
2026-10-09
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

REPATHAPrescription
EVOLOCUMAB 140MG/ML · INJECTABLE · INJECTION

Approval history

2026-10-09Efficacy · Supplement 47 · standard — Label ↗AP
2026-07-15Labeling · Supplement 49 · standard — Label ↗AP
2025-08-21Labeling · Supplement 45 · standard — Letter ↗AP
2024-11-20Labeling · Supplement 44 · standard — Label ↗AP
2024-08-20Labeling · Supplement 43 · standard — Letter ↗AP
2022-08-16Labeling · Supplement 33 · standard — Letter ↗AP
2021-09-24Efficacy · Supplement 29 · standard — Label ↗AP
2021-09-24Labeling · Supplement 31 · standard — Letter ↗AP
2021-02-26Efficacy · Original · standard — Label ↗AP
2020-05-06Manufacturing (CMC) · Supplement 24 — Letter ↗AP
2019-04-11Labeling · Supplement 20 · standard — Letter ↗AP
2019-02-15Labeling · Supplement 22 · standard — Label ↗AP
2019-02-15Labeling · Supplement 19 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 17 · standard — Letter ↗AP
2017-12-01Efficacy · Supplement 13 · priority — Label ↗AP
2017-12-01Efficacy · Supplement 14 · standard — Letter ↗AP
2017-01-25Labeling · Supplement 9 · standard — Label ↗AP
2017-01-03Labeling · Supplement 11 · standard — Label ↗AP
2016-11-30Labeling · Supplement 8 · standard — Label ↗AP
2016-07-08Labeling · Supplement 4 · standard — Review ↗AP
2016-07-08Efficacy · Supplement 1 · standard — Review ↗AP
2015-08-27Type 1 - New Molecular Entity · Original · standard — Label ↗AP