{"answer":{"query":"Takhzyro","resolved_as":"applications","packages":2,"applications":["BLA761090"],"identity":{"application_numbers":["BLA761090"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2022-02-08","latest":"2023-02-03","packages_with_a_start_date":2}},"label_history":{"events_total":4,"non_cmc_events":3,"counts_by_class":{"LABELING":2,"EFFICACY":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA761090","submission_no":20,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-20","documents":[{"type":"Letter","date":"2026-08-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761090Orig1s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761090s020lbl.pdf","untrusted":true}}],"fact_id":"cc4623d0c2ebfad08633d7b1"},{"application":"BLA761090","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-02-03","documents":[{"type":"Letter","date":"2023-02-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761090Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761090s010lbl.pdf","untrusted":true}}],"fact_id":"ed741427ad00fd662627cffc"},{"application":"BLA761090","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-11-16","documents":[{"type":"Label","date":"2018-11-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-11-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761090Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"fd982b663d4ff6ccfc462ecb"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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":"BLA761090","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TAKHZYRO","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300MG/2ML (150MG/ML)","untrusted":true}},{"application":"BLA761090","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TAKHZYRO","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300MG/2ML (150MG/ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Lanadelumab-Flyo","untrusted":true},"brand":{"text":"Takhzyro","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":151333291.05,"claims":3295,"beneficiaries":350,"average_spending_per_claim_usd":45928.161168,"fact_id":"65656ae992a6e4aa4e95e007"},{"year":2021,"gross_spending_usd":174024500.42,"claims":3809,"beneficiaries":394,"average_spending_per_claim_usd":45687.713421,"fact_id":"7787694eaefafd568f4b50c2"},{"year":2022,"gross_spending_usd":192066439.76,"claims":4189,"beneficiaries":428,"average_spending_per_claim_usd":45850.188532,"fact_id":"bdc24e5c6447b1298d71198e"},{"year":2023,"gross_spending_usd":194367297.26,"claims":4162,"beneficiaries":468,"average_spending_per_claim_usd":46700.455853,"fact_id":"bbef605c52d0af3853b799a0"},{"year":2024,"gross_spending_usd":223004902.8,"claims":4752,"beneficiaries":512,"average_spending_per_claim_usd":46928.641162,"fact_id":"6f513988f4f83d38fb1bf773"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; 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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:BLA761090","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":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"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."}