Cardiovascular Atlas
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Evolocumab (Repatha)

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.

Also called Repatha

  • Product
  • In this atlas

Overview

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.

Product details

Type
Medicine
Model or formulation
REPATHA (evolocumab) injection, 140 MG/ML strength per Drugs@FDA
Version
Label version 32, effective 2026-08-19 (openFDA label record)

Intended-use sources

  1. Background REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)

    Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: cd61e902-166d-4aa6-9f3c-a18c1008d07e

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-08-19
    Source state
    Current
    Snapshot hash
    d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e.json.

Claims and evidence

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)
Eligibility: inclusion criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    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.

    Applies to Recipient not specified
    • 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.
    • Prescription medicine, given by injection (Drugs@FDA route field)
    • United States (decision by the US Food and Drug Administration)
    • See the label indications; not stated in the application record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    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
    Next evidence check due
    Not scheduled
    Sources and citations (11)

    1. Supports Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · BLA: BLA125522

      Locator
      results[0].application_number: "BLA125522"
      How it applies
      Application number of this record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-BLA125522.json.

    2. Supports Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · BLA: BLA125522

      Locator
      results[0].products[0].brand_name: "REPATHA"
      How it applies
      Brand name.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-BLA125522.json.

    3. Supports Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · BLA: BLA125522

      Locator
      results[0].sponsor_name: "AMGEN INC"
      How it applies
      Applicant as the record writes it.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-BLA125522.json.

    4. Supports Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · BLA: BLA125522

      Locator
      results[0].submissions[21].submission_type: "ORIG"
      How it applies
      Original submission.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-BLA125522.json.

    5. Supports Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · BLA: BLA125522

      Locator
      results[0].submissions[21].submission_status: "AP"
      How it applies
      Approval status AP.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-BLA125522.json.

    6. Supports Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · BLA: BLA125522

      Locator
      results[0].submissions[21].submission_status_date: "20150827"
      How it applies
      Status date of the original submission, as eight digits.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-BLA125522.json.

    7. Supports Drugs@FDA overview page for BLA125522

      Regulator · U.S. Food and Drug Administration (Drugs@FDA) · 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.

      Locator
      Original Approvals or Tentative Approvals table, row ORIG-1
      How it applies
      Drugs@FDA page, original approval date written with slashes.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2cd897b6602287ded7c756d46a7741378dadd8332aa6ec1c3b546c93196dffc0
      Reuse basis
      The FDA website policies page (fetched as ch-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3, hash only) says that, unless otherwise noted, the contents of the FDA website (www.fda.gov) are not copyrighted and are in the public domain. This page is on the accessdata.fda.gov host of FDA; the policy page names www.fda.gov only, so the terms for this host are unverified and the source is cite_only: facts are stated in the atlas's own words, with no quoted span. The same Drugs@FDA data in the openFDA endpoint is released under CC0 (see the openFDA source). The raw page is committed at research/snapshots/cg-fda-daf-BLA125522.html.

    8. Supports Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda record, dataset last updated 2026-10-13. · BLA: BLA125522

      Locator
      results[0].submissions[21].submission_class_code_description: "Type 1 - New Molecular Entity"
      How it applies
      Submission class.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; terms page fetched as cg-openfda-terms.html, sha256 b11f712bfb11d03319675fc04e6948133a83c57aa2913b7f18d3677d0209f723). openFDA says its data is unvalidated and not for medical decisions. The raw file is committed at research/snapshots/cg-openfda-drugsfda-BLA125522.json.

    9. Supports REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: 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,"
      How it applies
      Label indications, first part (version 32, effective 2026-08-19).
      Retrieved
      Source effective date
      2026-08-19
      Source state
      Current
      Snapshot hash
      d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e.json.

    10. Supports REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: 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"
      How it applies
      Label indications, second part.
      Retrieved
      Source effective date
      2026-08-19
      Source state
      Current
      Snapshot hash
      d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e.json.

    11. Supports REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13. · SPL set id: 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"
      How it applies
      Label indications, third part.
      Retrieved
      Source effective date
      2026-08-19
      Source state
      Current
      Snapshot hash
      d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/cg-openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e.json.

Authorization

Regulatory decision: Evolocumab (Repatha)

Applies to Recipient not specified
  • 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.
  • Prescription medicine, given by injection (Drugs@FDA route field)
  • United States (decision by the US Food and Drug Administration)
  • See the label indications; not stated in the application record
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
BLA
Submission
BLA125522
Jurisdictions
United States; note: United States
Product version
REPATHA (evolocumab) injection, original application
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.
Basis
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.

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.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:repatha
Content hash
6bd09d9eb341b6ce511d4b8b08acc3db6fc70266b49d939a098aee21cc302db7