{"answer":{"query":"Skyrizi","resolved_as":"applications","packages":17,"applications":["BLA761105","BLA761262"],"identity":{"application_numbers":["BLA761105","BLA761262"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true},{"text":"KIT","untrusted":true},{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2021-04-26","latest":"2026-10-26","packages_with_a_start_date":17}},"label_history":{"events_total":27,"non_cmc_events":27,"counts_by_class":{"EFFICACY":13,"LABELING":14},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761105","submission_no":53,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-23","documents":[{"type":"Letter","date":"2026-10-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761105Orig1s053; 761262Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-10-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761105s053lbl.pdf","untrusted":true}}],"fact_id":"70741ea601f1d54ea96ad5ad"},{"application":"BLA761262","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-10-23","documents":[{"type":"Letter","date":"2026-10-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761105Orig1s053; 761262Orig1s019ltr.pdf","untrusted":true}}],"fact_id":"e46de2041599ea9589118864"},{"application":"BLA761105","submission_no":45,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-06-26","documents":[{"type":"Letter","date":"2026-06-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761105Orig1s045;761262Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761105s045lbl.pdf","untrusted":true}}],"fact_id":"b06b9f0d4c0cd11def52073d"},{"application":"BLA761262","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-26","documents":[{"type":"Letter","date":"2026-06-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761105Orig1s045;761262Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761262s016lbl.pdf","untrusted":true}}],"fact_id":"7dab35fffd5a3549a54b4396"},{"application":"BLA761105","submission_no":44,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-06-12","documents":[{"type":"Letter","date":"2026-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761105Orig1s044;76126Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761105s044lbl.pdf","untrusted":true}}],"fact_id":"f2b77a4f8fe86f9aff2b007d"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"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":"BLA761105","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SKYRIZI","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"150MG/ML","untrusted":true}},{"application":"BLA761105","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SKYRIZI","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"75MG/0.83ML","untrusted":true}},{"application":"BLA761262","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SKYRIZI","untrusted":true},"form":{"text":"INJECTABLE;INTRAVENOUS","untrusted":true},"strength":{"text":"600MG/VIAL","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"myAbbVie Assist","untrusted":true},"type":"manufacturer","url":"https://www.abbvie.com/patients/patient-assistance.html","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"TAF Cares (The Assistance Fund)","untrusted":true},"type":"nonprofit","url":"https://tafcares.org/","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. 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A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Risankizumab-Rzaa","untrusted":true},"brand":{"text":"Skyrizi*","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":76341483.57,"claims":4364,"beneficiaries":3030,"average_spending_per_claim_usd":17493.465529,"fact_id":"5af85bc3287b95cab5ec3a59"},{"year":2022,"gross_spending_usd":251093665.38,"claims":13327,"beneficiaries":4288,"average_spending_per_claim_usd":18840.974366,"fact_id":"3a881d0d9ceb7ba2c496e985"},{"year":2023,"gross_spending_usd":289245100.96,"claims":14749,"beneficiaries":4806,"average_spending_per_claim_usd":19611.166924,"fact_id":"268cf2ec4be6db0da4b3301b"},{"year":2024,"gross_spending_usd":315590527.52,"claims":16641,"beneficiaries":5557,"average_spending_per_claim_usd":18964.637192,"fact_id":"dece7f0a4256b7dc63f290c3"}],"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:BLA761105","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:BLA761262","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":"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."}