{"answer":{"query":"Tezspire","resolved_as":"applications","packages":4,"applications":["BLA761224"],"identity":{"application_numbers":["BLA761224"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2021-12-17","latest":"2024-02-20","packages_with_a_start_date":4}},"label_history":{"events_total":3,"non_cmc_events":3,"counts_by_class":{"EFFICACY":2,"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761224","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-10-17","documents":[{"type":"Label","date":"2025-10-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761224s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761224Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"3be4b69c58d3ff11d27bf00c"},{"application":"BLA761224","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-05-26","documents":[{"type":"Letter","date":"2023-05-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761224Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-05-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf","untrusted":true}}],"fact_id":"f628c556778a5287eff6b696"},{"application":"BLA761224","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-02-01","documents":[{"type":"Letter","date":"2023-02-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761224Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s001lbl.pdf","untrusted":true}}],"fact_id":"9411531c0e1aadc199a39644"}],"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":"BLA761224","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TEZSPIRE","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"210MG/1.91ML(110MG/ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Tezepelumab-Ekko","untrusted":true},"brand":{"text":"Tezspire","untrusted":true}},"latest_year":2024,"series":[{"year":2022,"gross_spending_usd":25810044.7,"claims":6512,"beneficiaries":1530,"average_spending_per_claim_usd":3963.4589527,"fact_id":"fba673a78a3c4362edbe9a19"},{"year":2023,"gross_spending_usd":88238001.89,"claims":20162,"beneficiaries":3451,"average_spending_per_claim_usd":4376.4508427,"fact_id":"e23df59765e6e73add284844"},{"year":2024,"gross_spending_usd":183765287.62,"claims":41254,"beneficiaries":6219,"average_spending_per_claim_usd":4454.4841135,"fact_id":"0117263e33c2e0d0d25706e2"}],"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:BLA761224","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."}