{"answer":{"query":"entyvio","resolved_as":"name","packages":5,"applications":["BLA761133","BLA125476"],"identity":{"application_numbers":["BLA761133","BLA125476"],"marketing_categories":["BLA"],"labelers":[{"text":"TAKEDA PHARMACEUTICALS AMERICA, INC.","untrusted":true}],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true},{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2014-05-20","latest":"2023-09-27","packages_with_a_start_date":3}},"label_history":{"events_total":20,"non_cmc_events":19,"counts_by_class":{"LABELING":18,"EFFICACY":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA125476","submission_no":66,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-25","documents":[{"type":"Letter","date":"2026-02-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125476Orig1s066,761133Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125476s66lbl.pdf","untrusted":true}}],"fact_id":"84f14d46afae943559a8daca"},{"application":"BLA761133","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-25","documents":[{"type":"Letter","date":"2026-02-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125476Orig1s066,761133Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761133s14lbl.pdf","untrusted":true}}],"fact_id":"52562aa477564d240869dbcd"},{"application":"BLA125476","submission_no":61,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-18","documents":[{"type":"Letter","date":"2024-04-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-05-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf","untrusted":true}}],"fact_id":"d93132c2cbef36758bef84bc"},{"application":"BLA125476","submission_no":60,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-18","documents":[{"type":"Letter","date":"2024-04-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-05-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s060s061lbl.pdf","untrusted":true}}],"fact_id":"acc33c4e8dea86c7b53797a2"},{"application":"BLA761133","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-18","documents":[{"type":"Letter","date":"2024-04-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-05-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761133s005s006lbl.pdf","untrusted":true}}],"fact_id":"54f39b19a2acb8be3e107179"}],"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":"BLA761133","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ENTYVIO","untrusted":true},"form":{"text":"INJECTABLE;INTRAVENOUS","untrusted":true},"strength":{"text":"300MG","untrusted":true}},{"application":"BLA761133","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ENTYVIO","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"108MG/0.68ML","untrusted":true}},{"application":"BLA125476","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ENTYVIO","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"300MG","untrusted":true}}]},"trials":{"attribution":"Source: ClinicalTrials.gov","modification_statement":"OmniRx has summarized and trimmed this ClinicalTrials.gov data.","not_an_offer":"A recruiting trial listing is not an offer of free drug and not medical advice; enrollment is decided by the study team.","ingredients":[{"ingredient":{"text":"VEDOLIZUMAB","untrusted":true},"recruiting_interventional_count":26,"not_yet_recruiting_count":5,"by_phase":{"PHASE3":7,"PHASE4":9,"PHASE2/PHASE3":2,"PHASE2":6,"PHASE1":1,"NA":1},"registry_processing_date":"2026-11-06T10:00:05","modifications":"Counts and phase tallies computed here from the full recruiting result set; trials trimmed to the 25 most recently updated, conditions to 3, countries to 10 distinct; no text edited.","recent_trials":[{"nct_id":"NCT05837897","title":{"text":"A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease","untrusted":true},"phase":["PHASE3"],"sponsor":{"text":"Takeda","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-02","start_date":"2023-06-16","link":{"text":"https://clinicaltrials.gov/study/NCT05837897","untrusted":true}},{"nct_id":"NCT06031233","title":{"text":"Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"Isala","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-10-29","start_date":"2023-09-01","link":{"text":"https://clinicaltrials.gov/study/NCT06031233","untrusted":true}},{"nct_id":"NCT06581328","title":{"text":"A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"Takeda","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-10-28","start_date":"2025-03-27","link":{"text":"https://clinicaltrials.gov/study/NCT06581328","untrusted":true}},{"nct_id":"NCT05928039","title":{"text":"PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"University of Calgary","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-10-26","start_date":"2023-10-25","link":{"text":"https://clinicaltrials.gov/study/NCT05928039","untrusted":true}},{"nct_id":"NCT06405087","title":{"text":"A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)","untrusted":true},"phase":["PHASE3"],"sponsor":{"text":"Takeda","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-10-09","start_date":"2025-10-27","link":{"text":"https://clinicaltrials.gov/study/NCT06405087","untrusted":true}}],"fact_id":"223dfda71176033971d3fc50"}]},"spending":{"reported_under":{"generic":{"text":"Vedolizumab","untrusted":true},"brand":{"text":"Entyvio","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":47057158.47,"claims":6552,"beneficiaries":1311,"average_spending_per_claim_usd":7182.1059936,"fact_id":"1ed17e0b651bcab3c9b7e351"},{"year":2021,"gross_spending_usd":58917162.66,"claims":7791,"beneficiaries":1505,"average_spending_per_claim_usd":7562.2080169,"fact_id":"fa36719269ce5a674256d81e"},{"year":2022,"gross_spending_usd":75974964.95,"claims":9428,"beneficiaries":1837,"average_spending_per_claim_usd":8058.4392183,"fact_id":"cb36b0b2e3dcc865365ac82f"},{"year":2023,"gross_spending_usd":99999922.74,"claims":11695,"beneficiaries":2238,"average_spending_per_claim_usd":8550.6560701,"fact_id":"d353b2cf2e0409bbd2e1e7cc"},{"year":2024,"gross_spending_usd":129249635.04,"claims":14773,"beneficiaries":2863,"average_spending_per_claim_usd":8749.0445434,"fact_id":"4754ea4e614a0851a276e667"}],"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; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"biologic_status":{"products":[{"application":"BLA761133","status":"Reference","name":{"text":"Entyvio; Entyvio Pen","untrusted":true},"proper_name":{"text":"vedolizumab","untrusted":true},"license_status":"Licensed","approval_date":"2023-09-27","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":"c3ae914bb4d75b78d375c968"},{"application":"BLA125476","status":"Reference","name":{"text":"Entyvio","untrusted":true},"proper_name":{"text":"vedolizumab","untrusted":true},"license_status":"Licensed","approval_date":"2014-05-20","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":"80ce77eb3a7be85bdbe99ef9"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"payment_limit":{"codes":[{"hcpcs":"J3380","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":20.949,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":1,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"3fe2f954b9be70b191d17170"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Vedolizumab; vedolizumab","untrusted":true},"designation_count":3,"approved_count":0,"recent":[{"designated":"2021-03-15","use":{"text":"Treatment of Pouchitis","untrusted":true},"status":"Designated","sponsor":{"text":"Takeda Development Center Americas, Inc.","untrusted":true},"approved":false},{"designated":"2017-03-21","use":{"text":"Treatment of graft versus host disease","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Takeda Development Center Americas, Inc.","untrusted":true},"approved":false},{"designated":"2016-08-04","use":{"text":"Prevention of graft versus host disease.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Takeda Development Center Americas, Inc.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"300258ed2d10ffc679e68494"}],"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":28,"all_states_medicaid_reimbursed_usd":39031413.53,"all_states_medicaid_paid_prescriptions":5924,"top_states":[{"state":"NY","medicaid_paid_prescriptions":663,"medicaid_reimbursed_usd":4356027.51,"total_reimbursed_usd":4390126.44,"packages":1,"covers":"all_record_types","fact_id":"78ae79ea756db48d3ee9c66a"},{"state":"AZ","medicaid_paid_prescriptions":471,"medicaid_reimbursed_usd":3078760.75,"total_reimbursed_usd":3129759.41,"packages":1,"covers":"all_record_types","fact_id":"8e728e5dd9d7c9cae60a3bf2"},{"state":"NC","medicaid_paid_prescriptions":382,"medicaid_reimbursed_usd":2562436.71,"total_reimbursed_usd":2683879.91,"packages":1,"covers":"fee_for_service_only","fact_id":"1ca19a63e2bee2a42c5d4680"},{"state":"PA","medicaid_paid_prescriptions":442,"medicaid_reimbursed_usd":2548099.2,"total_reimbursed_usd":2847567.31,"packages":1,"covers":"fee_for_service_only","fact_id":"d89be355ba69b99d5859ae1f"},{"state":"OH","medicaid_paid_prescriptions":338,"medicaid_reimbursed_usd":2361420.98,"total_reimbursed_usd":2396293.08,"packages":1,"covers":"fee_for_service_only","fact_id":"76b1f42b58174a431fdb4c5f"},{"state":"WA","medicaid_paid_prescriptions":316,"medicaid_reimbursed_usd":2085471.72,"total_reimbursed_usd":2135683.62,"packages":1,"covers":"fee_for_service_only","fact_id":"2c8d1915e6d553221ff9e9a6"},{"state":"KY","medicaid_paid_prescriptions":307,"medicaid_reimbursed_usd":1851489.66,"total_reimbursed_usd":1851489.66,"packages":1,"covers":"fee_for_service_only","fact_id":"0f8b63564912f25dd11643ed"},{"state":"IN","medicaid_paid_prescriptions":254,"medicaid_reimbursed_usd":1704459.4,"total_reimbursed_usd":1704459.4,"packages":1,"covers":"all_record_types","fact_id":"d02ffe558132fa76bac6299f"},{"state":"IL","medicaid_paid_prescriptions":240,"medicaid_reimbursed_usd":1677116.7,"total_reimbursed_usd":1677116.7,"packages":1,"covers":"fee_for_service_only","fact_id":"2c6e86697e610215d1e1f791"},{"state":"MI","medicaid_paid_prescriptions":242,"medicaid_reimbursed_usd":1629517.54,"total_reimbursed_usd":1629517.54,"packages":1,"covers":"fee_for_service_only","fact_id":"0caffed441740a407522b13c"}],"unlabelled_state_code_xx":null,"built_from_facts":28,"facts_fee_for_service_only":13,"older_year_facts_not_used":51,"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":"9ddba8e9de432c6cd63c1b20","field":"ndc.listing","entity":"ndc:64764010711"},{"fact_id":"fcd0454a3a7dcaeab36571a2","field":"ndc.listing","entity":"ndc:64764010821"},{"fact_id":"865562b92424de6431236ee9","field":"ndc.listing","entity":"ndc:64764030020"},{"fact_id":"84f14d46afae943559a8daca","field":"drug.label_event","entity":"application:BLA125476"},{"fact_id":"52562aa477564d240869dbcd","field":"drug.label_event","entity":"application:BLA761133"},{"fact_id":"d93132c2cbef36758bef84bc","field":"drug.label_event","entity":"application:BLA125476"},{"fact_id":"acc33c4e8dea86c7b53797a2","field":"drug.label_event","entity":"application:BLA125476"},{"fact_id":"54f39b19a2acb8be3e107179","field":"drug.label_event","entity":"application:BLA761133"},{"fact_id":"7e29fd5dd0f87cfa36899f47","field":"drug.marketing_status","entity":"application:BLA761133"},{"fact_id":"73281941e0282898f624776f","field":"drug.marketing_status","entity":"application:BLA761133"},{"fact_id":"9f68f2668f292cffe3c76621","field":"drug.marketing_status","entity":"application:BLA125476"},{"fact_id":"223dfda71176033971d3fc50","field":"drug.trial_access","entity":"drug:vedolizumab"},{"fact_id":"1ed17e0b651bcab3c9b7e351","field":"drug.partd_spending","entity":"drug:vedolizumab|entyvio"},{"fact_id":"fa36719269ce5a674256d81e","field":"drug.partd_spending","entity":"drug:vedolizumab|entyvio"},{"fact_id":"cb36b0b2e3dcc865365ac82f","field":"drug.partd_spending","entity":"drug:vedolizumab|entyvio"},{"fact_id":"d353b2cf2e0409bbd2e1e7cc","field":"drug.partd_spending","entity":"drug:vedolizumab|entyvio"},{"fact_id":"4754ea4e614a0851a276e667","field":"drug.partd_spending","entity":"drug:vedolizumab|entyvio"},{"fact_id":"c3ae914bb4d75b78d375c968","field":"drug.biologic_status","entity":"application:BLA761133"},{"fact_id":"80ce77eb3a7be85bdbe99ef9","field":"drug.biologic_status","entity":"application:BLA125476"},{"fact_id":"3fe2f954b9be70b191d17170","field":"drug.asp_price","entity":"hcpcs:J3380"},{"fact_id":"300258ed2d10ffc679e68494","field":"drug.orphan_designation","entity":"drug:vedolizumab"},{"fact_id":"78ae79ea756db48d3ee9c66a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:NY"},{"fact_id":"8e728e5dd9d7c9cae60a3bf2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:AZ"},{"fact_id":"1ca19a63e2bee2a42c5d4680","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:NC"},{"fact_id":"d89be355ba69b99d5859ae1f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:PA"},{"fact_id":"76b1f42b58174a431fdb4c5f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:OH"},{"fact_id":"2c8d1915e6d553221ff9e9a6","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:WA"},{"fact_id":"0f8b63564912f25dd11643ed","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:KY"},{"fact_id":"d02ffe558132fa76bac6299f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:IN"},{"fact_id":"2c6e86697e610215d1e1f791","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:IL"},{"fact_id":"0caffed441740a407522b13c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764010821:MI"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["AMBER","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:BLA761133","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:BLA125476","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":"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."}