{"answer":{"query":"Repatha","resolved_as":"applications","packages":10,"applications":["BLA125522"],"identity":{"application_numbers":["BLA125522"],"marketing_categories":["BLA"],"labelers":[{"text":"AMGEN USA INC.","untrusted":true}],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2018-10-09","latest":"2026-07-13","packages_with_a_start_date":10}},"label_history":{"events_total":20,"non_cmc_events":19,"counts_by_class":{"EFFICACY":5,"LABELING":14},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA125522","submission_no":47,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-09","documents":[{"type":"Label","date":"2026-10-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125522s047lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-10-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125522Orig1s047ltr.pdf","untrusted":true}}],"fact_id":"4762e0ce9782e0117f66c549"},{"application":"BLA125522","submission_no":49,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-07-15","documents":[{"type":"Label","date":"2026-07-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125522s049lbl.pdf","untrusted":true}}],"fact_id":"f16d67eb9f21e470f7e3a585"},{"application":"BLA125522","submission_no":45,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-21","documents":[{"type":"Letter","date":"2025-08-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125522Orig1s045ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-08-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125522s045lbl.pdf","untrusted":true}}],"fact_id":"ffed243f0f499a051fa63394"},{"application":"BLA125522","submission_no":44,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-20","documents":[{"type":"Label","date":"2024-11-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125522s044lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-11-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125522Orig1s044ltr.pdf","untrusted":true}}],"fact_id":"68810fe8c14f10a65ef52dd2"},{"application":"BLA125522","submission_no":43,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-20","documents":[{"type":"Letter","date":"2024-08-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125522Orig1s043ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125522s043lbl.pdf","untrusted":true}}],"fact_id":"173ec3570ce7ec2d01f94f89"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"BLA125522","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"REPATHA","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"140MG/ML","untrusted":true}}]},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":["2027-02-28"],"packages_with_future_termination_date":1,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Amgen Safety Net Foundation","untrusted":true},"type":"manufacturer","url":"https://www.amgensafetynetfoundation.com/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"biologic_status":{"products":[{"application":"BLA125522","status":"Reference","name":{"text":"Repatha","untrusted":true},"proper_name":{"text":"evolocumab","untrusted":true},"license_status":"Licensed","approval_date":"2015-08-27","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":0,"biosimilars":[],"interchangeables":[],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"e128d871618b275b908e0699"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"evolocumab","untrusted":true},"designation_count":3,"approved_count":3,"recent":[{"designated":"2013-09-12","use":{"text":"Treatment of homozygous familial hypercholesterolemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Amgen Inc.","untrusted":true},"approved":true},{"designated":"2013-09-12","use":{"text":"Treatment of homozygous familial hypercholesterolemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Amgen Inc.","untrusted":true},"approved":true},{"designated":"2013-09-12","use":{"text":"Treatment of homozygous familial hypercholesterolemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Amgen Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"9a5d4d6aaa2f4e2daa43143e"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":31,"all_states_medicaid_reimbursed_usd":12458926.19,"all_states_medicaid_paid_prescriptions":21071,"top_states":[{"state":"CA","medicaid_paid_prescriptions":6191,"medicaid_reimbursed_usd":3412869.72,"total_reimbursed_usd":3455641.92,"packages":1,"covers":"all_record_types","fact_id":"274874c6f90d524024e8a936"},{"state":"NY","medicaid_paid_prescriptions":4081,"medicaid_reimbursed_usd":2852835.8,"total_reimbursed_usd":2863890.38,"packages":1,"covers":"fee_for_service_only","fact_id":"2d7e65943080252e6c655703"},{"state":"KY","medicaid_paid_prescriptions":1578,"medicaid_reimbursed_usd":900242.27,"total_reimbursed_usd":900242.27,"packages":1,"covers":"fee_for_service_only","fact_id":"741a392ecf6c1dd8f5150321"},{"state":"FL","medicaid_paid_prescriptions":973,"medicaid_reimbursed_usd":546761.95,"total_reimbursed_usd":550343.13,"packages":1,"covers":"fee_for_service_only","fact_id":"81eec1cf43b5a21d956119bf"},{"state":"MI","medicaid_paid_prescriptions":850,"medicaid_reimbursed_usd":467371.75,"total_reimbursed_usd":467371.75,"packages":1,"covers":"fee_for_service_only","fact_id":"2887c4b72a7f9d11a431b170"},{"state":"OH","medicaid_paid_prescriptions":713,"medicaid_reimbursed_usd":377325.59,"total_reimbursed_usd":378576,"packages":1,"covers":"fee_for_service_only","fact_id":"47b6a49d83285492c89b6371"},{"state":"IL","medicaid_paid_prescriptions":521,"medicaid_reimbursed_usd":345837.2,"total_reimbursed_usd":345837.2,"packages":1,"covers":"fee_for_service_only","fact_id":"3a32203ab0046d14fe5afe59"},{"state":"PA","medicaid_paid_prescriptions":550,"medicaid_reimbursed_usd":341365.09,"total_reimbursed_usd":350653.67,"packages":1,"covers":"fee_for_service_only","fact_id":"1c4347a2b34b1da93dbe15d1"},{"state":"IN","medicaid_paid_prescriptions":442,"medicaid_reimbursed_usd":290580.81,"total_reimbursed_usd":290580.81,"packages":1,"covers":"fee_for_service_only","fact_id":"920e715dd18daaf0be613e83"},{"state":"MO","medicaid_paid_prescriptions":498,"medicaid_reimbursed_usd":272112.89,"total_reimbursed_usd":277383.27,"packages":1,"covers":"all_record_types","fact_id":"9878979054685164b76ae538"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":22089,"medicaid_reimbursed_usd":12999750.38,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":32,"facts_fee_for_service_only":17,"older_year_facts_not_used":88,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"a931949f28d695a51e6a9c67","field":"ndc.listing","entity":"ndc:72511014301"},{"fact_id":"fd53096b2a9fd9f52eb8fb95","field":"ndc.listing","entity":"ndc:72511014302"},{"fact_id":"8bb4ebe1c593f2f62e925ef8","field":"ndc.listing","entity":"ndc:72511014396"},{"fact_id":"4762e0ce9782e0117f66c549","field":"drug.label_event","entity":"application:BLA125522"},{"fact_id":"f16d67eb9f21e470f7e3a585","field":"drug.label_event","entity":"application:BLA125522"},{"fact_id":"ffed243f0f499a051fa63394","field":"drug.label_event","entity":"application:BLA125522"},{"fact_id":"68810fe8c14f10a65ef52dd2","field":"drug.label_event","entity":"application:BLA125522"},{"fact_id":"173ec3570ce7ec2d01f94f89","field":"drug.label_event","entity":"application:BLA125522"},{"fact_id":"6966338c2e0cffd9da9330b3","field":"drug.marketing_status","entity":"application:BLA125522"},{"fact_id":"b9a1894f0bdbd568cc3754db","field":"ndc.product","entity":"ndc:72511075001"},{"fact_id":"e128d871618b275b908e0699","field":"drug.biologic_status","entity":"application:BLA125522"},{"fact_id":"9a5d4d6aaa2f4e2daa43143e","field":"drug.orphan_designation","entity":"drug:evolocumab"},{"fact_id":"274874c6f90d524024e8a936","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:CA"},{"fact_id":"2d7e65943080252e6c655703","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:NY"},{"fact_id":"741a392ecf6c1dd8f5150321","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:KY"},{"fact_id":"81eec1cf43b5a21d956119bf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:FL"},{"fact_id":"2887c4b72a7f9d11a431b170","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:MI"},{"fact_id":"47b6a49d83285492c89b6371","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:OH"},{"fact_id":"3a32203ab0046d14fe5afe59","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:IL"},{"fact_id":"1c4347a2b34b1da93dbe15d1","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:PA"},{"fact_id":"920e715dd18daaf0be613e83","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:IN"},{"fact_id":"9878979054685164b76ae538","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72511050101:MO"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:BLA125522","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"spending","reason":"no CMS Part D spending series for this brand name is in the edition"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}