Lowers the risk of major adverse cardiovascular (CV) events (CV death, myocardial…. BLA 125522, held by Amgen Inc. Evolocumab.
As of Nov 13, 2026, BLA 125522 (Repatha), held by Amgen Inc, was first approved by FDA on Feb 26, 2021, with 20 approved supplements and 1 published complete response letter.
REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, coronary revascularization, or any ischemia-driven arterial revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2026 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Sep 24, 2021 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Feb 26, 2021 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2017 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Jul 8, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 27, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Aug 27, 2015 | Repatha (evolocumab)Clinical, Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Repatha140MG/ML · injectable;injection | Evolocumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2026 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Jul 15, 2026 | Supplement 49Labeling · Standard review | Approved | |
| Aug 21, 2025 | Supplement 45Labeling · Standard review | Approved | |
| Nov 20, 2024 | Supplement 44Labeling · Standard review | Approved | |
| Aug 20, 2024 | Supplement 43Labeling · Standard review | Approved | |
| Aug 16, 2022 | Supplement 33Labeling · Standard review | Approved | |
| Sep 24, 2021 | Supplement 31Labeling · Standard review | Approved | |
| Sep 24, 2021 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Feb 26, 2021 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| May 6, 2020 | Supplement 24Manufacturing | Approved | |
| Apr 11, 2019 | Supplement 20Labeling · Standard review | Approved | |
| Feb 15, 2019 | Supplement 22Labeling · Standard review | Approved | |
| Feb 15, 2019 | Supplement 19Labeling · Standard review | Approved | |
| Oct 18, 2018 | Supplement 17Labeling · Standard review | Approved | |
| Dec 1, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2017 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Jan 25, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Jan 3, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Nov 30, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Jul 8, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Jul 8, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 27, 2015 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
