{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:leqvio", "owner": "cardio", "kind": "product", "slug": "leqvio", "name": "Inclisiran (Leqvio)", "aliases": [ "Leqvio" ], "atlases": [ "cardio" ], "summary_plain": "Leqvio is the brand name of inclisiran, a small interfering RNA medicine that a health professional gives by injection to lower LDL cholesterol. The US FDA first approved it in December 2021. Its outcome trial, ORION-4, has not reported results.", "summary_technical": "FDA application NDA214012, applicant Novartis (Drugs@FDA); original approval status date 2021-12-22. The current openFDA label record is version 13, effective 2026-08-19, and its manufacturer field reads Novartis Pharmaceuticals Corporation. The label describes inclisiran as an siRNA that directs breakdown of the messenger RNA for PCSK9. The label lists the use as lowering LDL-C and does not report an inclisiran outcomes result.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "spl-set-id", "value": "6fc0afca-4513-4c35-b594-6544aee29a44", "normalized_value": "6fc0afca-4513-4c35-b594-6544aee29a44", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "condition-area": [ "coronary-and-vascular-disease" ] } }, "payload": { "subtype": "medicine", "model_or_formulation": "LEQVIO (inclisiran) injection, 284 mg/1.5 mL single-dose prefilled syringe per the label", "version": "Label version 13, effective 2026-08-19 (openFDA label record)", "intended_use_snapshots": [ "cardio:openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44-2026-10-14" ] }, "content_digest": "726fa63d6a8e3f2ff388ad1119f712140ed8e4d8a06e6ab380e8bafde02cf492", "review": { "content_digest": "726fa63d6a8e3f2ff388ad1119f712140ed8e4d8a06e6ab380e8bafde02cf492", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fda-leqvio-nda214012-approval", "owner": "cardio", "subject_entity_id": "cardio:leqvio", "category": "regulatory", "statement": "The US Food and Drug Administration approved LEQVIO (inclisiran) under new drug application NDA214012. The Drugs@FDA record lists an original submission (number 1, class Type 1 - New Molecular Entity) with approval status AP dated 22 December 2021, and NOVARTIS as the applicant. The current label states that LEQVIO is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, in heterozygous familial hypercholesterolemia from age 12, and in children aged 12 and older with homozygous familial hypercholesterolemia.", "context": { "id": "cardio:ctx-fda-leqvio-us-approval", "label": "United States FDA approval record NDA214012 for LEQVIO", "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 20211222 there. The indications are those of the current label (version 13, effective 2026-08-19), which have changed since 2021 through supplements, so they are not the 2021 indications. The label also says cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events in adults at increased risk treated with statins or monoclonal antibody PCSK9 inhibitors; it does not say that LEQVIO itself has shown this, and this record does not claim it (the ORION-4 trial, which tests inclisiran, had not reported when this record was written). This record states the decision and the label wording only.", "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: \"NDA214012\"", "applicability_note": "Application number of this record.", "snapshot": { "id": "cardio:openfda-drugsfda-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:22:03Z", "content_hash": "9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda214012", "source_type": "regulator", "title": "Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012", "identifiers": [ { "scheme": "fda-nda", "value": "NDA214012", "normalized_value": "NDA214012", "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-NDA214012.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].products[0].brand_name: \"LEQVIO\"", "applicability_note": "Brand name.", "snapshot": { "id": "cardio:openfda-drugsfda-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:22:03Z", "content_hash": "9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda214012", "source_type": "regulator", "title": "Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012", "identifiers": [ { "scheme": "fda-nda", "value": "NDA214012", "normalized_value": "NDA214012", "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-NDA214012.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].sponsor_name: \"NOVARTIS\"", "applicability_note": "Applicant as the record writes it.", "snapshot": { "id": "cardio:openfda-drugsfda-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:22:03Z", "content_hash": "9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda214012", "source_type": "regulator", "title": "Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012", "identifiers": [ { "scheme": "fda-nda", "value": "NDA214012", "normalized_value": "NDA214012", "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-NDA214012.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].submissions[0].submission_type: \"ORIG\"", "applicability_note": "Original submission.", "snapshot": { "id": "cardio:openfda-drugsfda-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:22:03Z", "content_hash": "9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda214012", "source_type": "regulator", "title": "Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012", "identifiers": [ { "scheme": "fda-nda", "value": "NDA214012", "normalized_value": "NDA214012", "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-NDA214012.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].submissions[0].submission_status: \"AP\"", "applicability_note": "Approval status AP.", "snapshot": { "id": "cardio:openfda-drugsfda-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:22:03Z", "content_hash": "9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda214012", "source_type": "regulator", "title": "Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012", "identifiers": [ { "scheme": "fda-nda", "value": "NDA214012", "normalized_value": "NDA214012", "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-NDA214012.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].submissions[0].submission_status_date: \"20211222\"", "applicability_note": "Status date of the original submission, as eight digits.", "snapshot": { "id": "cardio:openfda-drugsfda-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:22:03Z", "content_hash": "9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda214012", "source_type": "regulator", "title": "Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012", "identifiers": [ { "scheme": "fda-nda", "value": "NDA214012", "normalized_value": "NDA214012", "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-NDA214012.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-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:35:14Z", "content_hash": "e373b8e2adf9c57a2ddcc4530e68aeb7c64b1abbb4c1f1b5d567815c4bb96a2a", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:fda-daf-nda214012", "source_type": "regulator", "title": "Drugs@FDA overview page for NDA214012", "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214012", "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-NDA214012.html.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "results[0].submissions[0].submission_class_code_description: \"Type 1 - New Molecular Entity\"", "applicability_note": "Submission class.", "snapshot": { "id": "cardio:openfda-drugsfda-nda214012-2026-10-14", "retrieved_at": "2026-10-14T18:22:03Z", "content_hash": "9c7ca4284290883d88889705d77718718121998f91b5cf01d2e0346a094b903c", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-drugsfda-nda214012", "source_type": "regulator", "title": "Drugs@FDA application NDA214012: LEQVIO (inclisiran) (openFDA drugsfda record)", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214012", "identifiers": [ { "scheme": "fda-nda", "value": "NDA214012", "normalized_value": "NDA214012", "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-NDA214012.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].indications_and_usage[0]: \"1 INDICATIONS AND USAGE LEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:\"", "applicability_note": "Label indications, first part (version 13, effective 2026-08-19).", "snapshot": { "id": "cardio:openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44-2026-10-14", "retrieved_at": "2026-10-14T18:22:13Z", "content_hash": "58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06", "source_effective_date": "2026-08-19", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44", "source_type": "label", "title": "LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44", "identifiers": [ { "scheme": "spl-set-id", "value": "6fc0afca-4513-4c35-b594-6544aee29a44", "normalized_value": "6fc0afca-4513-4c35-b594-6544aee29a44", "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-6fc0afca-4513-4c35-b594-6544aee29a44.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].indications_and_usage[0]: \"adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older\"", "applicability_note": "Label indications, second part.", "snapshot": { "id": "cardio:openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44-2026-10-14", "retrieved_at": "2026-10-14T18:22:13Z", "content_hash": "58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06", "source_effective_date": "2026-08-19", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44", "source_type": "label", "title": "LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44", "identifiers": [ { "scheme": "spl-set-id", "value": "6fc0afca-4513-4c35-b594-6544aee29a44", "normalized_value": "6fc0afca-4513-4c35-b594-6544aee29a44", "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-6fc0afca-4513-4c35-b594-6544aee29a44.json.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].indications_and_usage[0]: \"with homozygous familial hypercholesterolemia (HoFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE)\"", "applicability_note": "Label indications, third part.", "snapshot": { "id": "cardio:openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44-2026-10-14", "retrieved_at": "2026-10-14T18:22:13Z", "content_hash": "58e7283ce7a643577b6766337f70c3e7877adf1c139f4d23da7ec6ce0a01fd06", "source_effective_date": "2026-08-19", "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:openfda-label-6fc0afca-4513-4c35-b594-6544aee29a44", "source_type": "label", "title": "LEQVIO drug label (openFDA record, set id 6fc0afca-4513-4c35-b594-6544aee29a44)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44", "identifiers": [ { "scheme": "spl-set-id", "value": "6fc0afca-4513-4c35-b594-6544aee29a44", "normalized_value": "6fc0afca-4513-4c35-b594-6544aee29a44", "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-6fc0afca-4513-4c35-b594-6544aee29a44.json.", "public_text": "quote" } } ], "review": { "content_digest": "7746fb23642f8d8e3b18c9bd545f7fe909e0b19e8017c3413b83a0a7ab70edf6", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-fda-leqvio-nda214012-approval.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "cardio:regdec-fda-leqvio-nda214012", "product_id": "cardio:leqvio", "product_version": "LEQVIO (inclisiran) injection, original application", "indication": "Not read from the original approval. The 2021 label was not fetched. 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