# Evolocumab (Repatha)

Product · id `cardio:repatha` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: Repatha

Browse, condition area: Coronary and vascular disease  

## In plain language

Repatha is the brand name of evolocumab, an antibody given by injection under the skin that lowers LDL cholesterol by blocking PCSK9. The US FDA first approved it in August 2015. Its label says it is used to lower the risk of heart attack, stroke and other major cardiovascular events in adults at increased risk, and to lower LDL cholesterol.

## Technical summary

FDA application BLA125522, applicant Amgen Inc (Drugs@FDA); original approval status date 2015-08-27. The current openFDA label record is version 32, effective 2026-08-19, labeler Amgen USA Inc. The FDA pharmacologic class on the label is PCSK9 Inhibitor. The outcomes evidence for evolocumab is in the record of its outcomes trial.

## Claims, with the population each applies to

## Context: United States FDA approval record BLA125522 for REPATHA

Recipient: Recipient not specified; Population: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Care setting: Prescription medicine, given by injection (Drugs@FDA route field); Geography: United States (decision by the US Food and Drug Administration); Life stage: See the label indications; not stated in the application record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)

### The US Food and Drug Administration approved REPATHA (evolocumab) under biologics license application BLA125522. The Drugs@FDA record lists an original submission (number 1, class Type 1 - New Molecular Entity) with approval status AP dated 27 August 2015, and AMGEN INC as the applicant. The current label states that REPATHA is indicated to reduce the risk of major adverse cardiovascular events in adults at increased risk for these events, and as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia and in heterozygous familial hypercholesterolemia from age 10, with further indications listed.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: Recipient: Recipient not specified; Population: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Care setting: Prescription medicine, given by injection (Drugs@FDA route field); Geography: United States (decision by the US Food and Drug Administration); Life stage: See the label indications; not stated in the application record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Limitations: openFDA says its data is unvalidated and not for medical decisions. The approval date is the status date of the original submission in the Drugs@FDA record, written as 20150827 there. The indications are those of the current label (version 32, effective 2026-08-19), which the FDA has changed since 2015 through many supplements, so they are not the 2015 indications. This record states the decision and the label wording and is not a finding about how well the medicine works.
- Last checked: 2026-10-14
- Sources:
  1. Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522>
     Locator: results\[0\].application\_number: "BLA125522". Retrieved 2026-10-14T18:22:02Z. Source state: Current. Snapshot hash: f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1.
     How it applies: Application number of this record.
  2. Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522>
     Locator: results\[0\].products\[0\].brand\_name: "REPATHA". Retrieved 2026-10-14T18:22:02Z. Source state: Current. Snapshot hash: f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1.
     How it applies: Brand name.
  3. Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522>
     Locator: results\[0\].sponsor\_name: "AMGEN INC". Retrieved 2026-10-14T18:22:02Z. Source state: Current. Snapshot hash: f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1.
     How it applies: Applicant as the record writes it.
  4. Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522>
     Locator: results\[0\].submissions\[21\].submission\_type: "ORIG". Retrieved 2026-10-14T18:22:02Z. Source state: Current. Snapshot hash: f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1.
     How it applies: Original submission.
  5. Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522>
     Locator: results\[0\].submissions\[21\].submission\_status: "AP". Retrieved 2026-10-14T18:22:02Z. Source state: Current. Snapshot hash: f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1.
     How it applies: Approval status AP.
  6. Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522>
     Locator: results\[0\].submissions\[21\].submission\_status\_date: "20150827". Retrieved 2026-10-14T18:22:02Z. Source state: Current. Snapshot hash: f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1.
     How it applies: Status date of the original submission, as eight digits.
  7. Supports: Drugs@FDA overview page for BLA125522 (Regulator, edition Page fetched 2026-10-14. It writes the approval date as month, day, year with slashes; the openFDA JSON writes the same date as eight digits.) <https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125522>
     Locator: Original Approvals or Tentative Approvals table, row ORIG-1. Retrieved 2026-10-14T18:35:09Z. Source state: Current. Snapshot hash: 2cd897b6602287ded7c756d46a7741378dadd8332aa6ec1c3b546c93196dffc0.
     How it applies: Drugs@FDA page, original approval date written with slashes.
  8. Supports: Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record) (Regulator, edition openFDA drugsfda record, dataset last updated 2026-10-13.) <https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522>
     Locator: results\[0\].submissions\[21\].submission\_class\_code\_description: "Type 1 - New Molecular Entity". Retrieved 2026-10-14T18:22:02Z. Source state: Current. Snapshot hash: f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1.
     How it applies: Submission class.
  9. Supports: REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e) (Label, edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.) <https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e>
     Locator: results\[0\].indications\_and\_usage\[0\]: "1 INDICATIONS AND USAGE REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke,". Retrieved 2026-10-14T18:22:13Z. Source state: Current. Snapshot hash: d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6.
     How it applies: Label indications, first part (version 32, effective 2026-08-19).
  10. Supports: REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e) (Label, edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.) <https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e>
     Locator: results\[0\].indications\_and\_usage\[0\]: "unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce". Retrieved 2026-10-14T18:22:13Z. Source state: Current. Snapshot hash: d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6.
     How it applies: Label indications, second part.
  11. Supports: REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e) (Label, edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.) <https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e>
     Locator: results\[0\].indications\_and\_usage\[0\]: "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". Retrieved 2026-10-14T18:22:13Z. Source state: Current. Snapshot hash: d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6.
     How it applies: Label indications, third part.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-repatha-bla125522`

- Product: Evolocumab (Repatha) (`cardio:repatha`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2015-08-27
- Product version: REPATHA (evolocumab) injection, original application
- Pathway: BLA
- Submission: BLA125522
- Indication: Not read from the original approval. The 2015 label was not fetched. The current label wording (version 32, 2026-08-19) is in the linked claim; it includes uses that may have been added after 2015.
- Jurisdictions: United States; note: United States
- Applies to: Recipient: Recipient not specified; Population: Set by the product label. The Drugs@FDA application record names the product and applicant and gives no population; the current label states the indications.; Care setting: Prescription medicine, given by injection (Drugs@FDA route field); Geography: United States (decision by the US Food and Drug Administration); Life stage: See the label indications; not stated in the application record; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision)
- Basis: claim `cardio:claim-fda-repatha-bla125522-approval`

## Connected pages

- Active ingredient: Evolocumab (`cardio:evolocumab`)
- Files under this front: Medicines (`cardio:front-medicines`)

## Provenance

Content hash: 6bd09d9eb341b6ce511d4b8b08acc3db6fc70266b49d939a098aee21cc302db7
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14