Lowers the risk of major adverse cardiovascular (CV) events (coronary heart disease…. BLA 125559, held by Regeneron Pharmaceuticals. Alirocumab.
As of Nov 13, 2026, BLA 125559 (Praluent), held by Regeneron Pharmaceuticals, was first approved by FDA on Jul 24, 2015, with 13 approved supplements and 0 published complete response letters.
PRALUENT is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) 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 8 years and older with heterozygous familial hypercholesterolemia (HeFH). adults with homozygous familial hypercholesterolemia (HoFH).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2025 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Mar 8, 2024 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Apr 1, 2021 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2019 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2019 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Aug 22, 2018 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Sep 20, 2017 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Apr 24, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Praluent75MG · injectable;injection | Alirocumab | Rx |
| Praluent150MG · injectable;injection | Alirocumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2025 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Mar 8, 2024 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Apr 1, 2021 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Apr 1, 2021 | Supplement 30Labeling · Standard review | Approved | |
| Mar 10, 2020 | Supplement 24Labeling · Standard review | Approved | |
| Apr 26, 2019 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2019 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Nov 6, 2018 | Supplement 18Labeling · Standard review | Approved | |
| Aug 22, 2018 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jul 20, 2018 | Supplement 15Labeling · Standard review | Approved | |
| Sep 20, 2017 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2017 | Supplement 2Manufacturing · Standard review | Approved | |
| Apr 24, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 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
