{ "release_id": "5dcd9b263fe17744", "id": "cardio:repatha", "owner": "cardio", "kind": "product", "slug": "repatha", "name": "Evolocumab (Repatha)", "aliases": [ "Repatha" ], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "spl-set-id", "value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "normalized_value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "condition-area": [ "coronary-and-vascular-disease" ] } }, "payload": { "subtype": "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_snapshots": [ "cardio:openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e-2026-10-14" ] }, "content_digest": "6bd09d9eb341b6ce511d4b8b08acc3db6fc70266b49d939a098aee21cc302db7", "review": { "content_digest": "6bd09d9eb341b6ce511d4b8b08acc3db6fc70266b49d939a098aee21cc302db7", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "5dcd9b263fe17744", "id": "cardio:claim-fda-repatha-bla125522-approval", "owner": "cardio", "subject_entity_id": "cardio:repatha", "category": "regulatory", "statement": "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.", "context": { "id": "cardio:ctx-fda-repatha-us-approval", "label": "United States FDA approval record BLA125522 for REPATHA", "recipient": "unknown", "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_note": "See the label indications; not stated in the application record", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory decision)", "eligibility": { "inclusion": [], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].application_number: \"BLA125522\"", "applicability_note": "Application number of this record.", "snapshot": { "id": "cardio:openfda-drugsfda-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:22:02Z", "content_hash": "f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-bla125522", "source_type": "regulator", "title": "Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522", "identifiers": [ { "scheme": "fda-bla", "value": "BLA125522", "normalized_value": "BLA125522", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda record, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].products[0].brand_name: \"REPATHA\"", "applicability_note": "Brand name.", "snapshot": { "id": "cardio:openfda-drugsfda-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:22:02Z", "content_hash": "f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-bla125522", "source_type": "regulator", "title": "Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522", "identifiers": [ { "scheme": "fda-bla", "value": "BLA125522", "normalized_value": "BLA125522", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda record, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].sponsor_name: \"AMGEN INC\"", "applicability_note": "Applicant as the record writes it.", "snapshot": { "id": "cardio:openfda-drugsfda-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:22:02Z", "content_hash": "f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-bla125522", "source_type": "regulator", "title": "Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522", "identifiers": [ { "scheme": "fda-bla", "value": "BLA125522", "normalized_value": "BLA125522", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda record, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].submissions[21].submission_type: \"ORIG\"", "applicability_note": "Original submission.", "snapshot": { "id": "cardio:openfda-drugsfda-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:22:02Z", "content_hash": "f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-bla125522", "source_type": "regulator", "title": "Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522", "identifiers": [ { "scheme": "fda-bla", "value": "BLA125522", "normalized_value": "BLA125522", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda record, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].submissions[21].submission_status: \"AP\"", "applicability_note": "Approval status AP.", "snapshot": { "id": "cardio:openfda-drugsfda-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:22:02Z", "content_hash": "f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-bla125522", "source_type": "regulator", "title": "Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522", "identifiers": [ { "scheme": "fda-bla", "value": "BLA125522", "normalized_value": "BLA125522", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda record, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].submissions[21].submission_status_date: \"20150827\"", "applicability_note": "Status date of the original submission, as eight digits.", "snapshot": { "id": "cardio:openfda-drugsfda-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:22:02Z", "content_hash": "f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-bla125522", "source_type": "regulator", "title": "Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522", "identifiers": [ { "scheme": "fda-bla", "value": "BLA125522", "normalized_value": "BLA125522", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda record, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Original Approvals or Tentative Approvals table, row ORIG-1", "applicability_note": "Drugs@FDA page, original approval date written with slashes.", "snapshot": { "id": "cardio:fda-daf-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:35:09Z", "content_hash": "2cd897b6602287ded7c756d46a7741378dadd8332aa6ec1c3b546c93196dffc0", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-daf-bla125522", "source_type": "regulator", "title": "Drugs@FDA overview page for BLA125522", "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125522", "identifiers": [], "publication_date": null, "publisher": "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.", "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.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "results[0].submissions[21].submission_class_code_description: \"Type 1 - New Molecular Entity\"", "applicability_note": "Submission class.", "snapshot": { "id": "cardio:openfda-drugsfda-bla125522-2026-10-14", "retrieved_at": "2026-10-14T18:22:02Z", "content_hash": "f06e5e90ac381a6f30053f7c331c5ddd4b85955452ed347ffb4ec13b1658eba1", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-bla125522", "source_type": "regulator", "title": "Drugs@FDA application BLA125522: REPATHA (evolocumab) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA125522", "identifiers": [ { "scheme": "fda-bla", "value": "BLA125522", "normalized_value": "BLA125522", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda record, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "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,\"", "applicability_note": "Label indications, first part (version 32, effective 2026-08-19).", "snapshot": { "id": "cardio:openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e-2026-10-14", "retrieved_at": "2026-10-14T18:22:13Z", "content_hash": "d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6", "source_effective_date": "2026-08-19", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e", "source_type": "label", "title": "REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "identifiers": [ { "scheme": "spl-set-id", "value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "normalized_value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drug label endpoint)", "edition": "openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "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\"", "applicability_note": "Label indications, second part.", "snapshot": { "id": "cardio:openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e-2026-10-14", "retrieved_at": "2026-10-14T18:22:13Z", "content_hash": "d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6", "source_effective_date": "2026-08-19", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e", "source_type": "label", "title": "REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "identifiers": [ { "scheme": "spl-set-id", "value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "normalized_value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drug label endpoint)", "edition": "openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "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\"", "applicability_note": "Label indications, third part.", "snapshot": { "id": "cardio:openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e-2026-10-14", "retrieved_at": "2026-10-14T18:22:13Z", "content_hash": "d00be081acc925c1690754e0a729e3a8975dd499e3013d7153839980fa57f7d6", "source_effective_date": "2026-08-19", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-label-cd61e902-166d-4aa6-9f3c-a18c1008d07e", "source_type": "label", "title": "REPATHA drug label (openFDA record, set id cd61e902-166d-4aa6-9f3c-a18c1008d07e)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "identifiers": [ { "scheme": "spl-set-id", "value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "normalized_value": "cd61e902-166d-4aa6-9f3c-a18c1008d07e", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drug label endpoint)", "edition": "openFDA drug label record, label effective 20260819, dataset last updated 2026-10-13.", "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.", "public_text": "quote" } } ], "review": { "content_digest": "1e1e36aed897603c9c00ac65f9fd440b6729be3f2874dadd65130b449b6b1fc3", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-repatha-bla125522-approval.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "cardio:regdec-fda-repatha-bla125522", "product_id": "cardio:repatha", "product_version": "REPATHA (evolocumab) injection, original application", "indication": "Not read from the original approval. The 2015 label was not fetched. 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