{"id":"eftrenonacog-alfa","rwe":[{"pmid":"39101128","year":"2024","title":"Real-world usage and effectiveness of recombinant factor VIII/factor IX Fc in hemophilia A/B: final data from the 24-month, prospective, noninterventional PREVENT study in Germany.","finding":"","journal":"Research and practice in thrombosis and haemostasis","studyType":"Clinical Study"},{"pmid":"38333660","year":"2024","title":"Portal vein thrombosis in a patient with severe hemophilia B: A challenging balanced management.","finding":"","journal":"Clinical case reports","studyType":"Clinical Study"},{"pmid":"38070040","year":"2024","title":"Matching-Adjusted Indirect Comparison of Recombinant Factor IX Albumin Fusion Protein Versus Recombinant Factor IX Fc Fusion Protein for Weekly Prophylactic Treatment of Hemophilia B.","finding":"","journal":"Advances in therapy","studyType":"Clinical Study"},{"pmid":"37720484","year":"2023","title":"Long-term outcomes of prophylaxis with a recombinant factor VIII Fc or recombinant factor IX Fc in patients with hemophilia previously treated on demand.","finding":"","journal":"Research and practice in thrombosis and haemostasis","studyType":"Clinical Study"},{"pmid":"37222971","year":"2023","title":"Correction to: Eftrenonacog Alfa: A Review in Haemophilia B.","finding":"","journal":"Drugs","studyType":"Clinical Study"}],"tags":[{"label":"Biologic","category":"modality"},{"label":"Active","category":"status"},{"label":"Hereditary factor IX deficiency disease","category":"indication"},{"label":"Swedish Orphan Biovitrum AB","category":"company"}],"phase":"marketed","safety":{"safetySignals":[{"llr":1158.564,"date":"","count":279,"signal":"Haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 279 times (LLR=1159)"},{"llr":452.191,"date":"","count":79,"signal":"Haemarthrosis","source":"DrugCentral FAERS","actionTaken":"Reported 79 times (LLR=452)"},{"llr":257.428,"date":"","count":29,"signal":"Factor IX inhibition","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=257)"},{"llr":162.64,"date":"","count":25,"signal":"Spontaneous haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=163)"},{"llr":109.874,"date":"","count":19,"signal":"Traumatic haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=110)"},{"llr":106.966,"date":"","count":24,"signal":"Muscle haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=107)"},{"llr":74.498,"date":"","count":42,"signal":"Contusion","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=74)"},{"llr":61.268,"date":"","count":6,"signal":"Coagulation factor IX level decreased","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=61)"}],"commonSideEffects":[{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Oral paresthesia","drugRate":"","severity":"common","organSystem":""},{"effect":"Obstructive uropathy","drugRate":"","severity":"common","organSystem":""},{"effect":"Injection site erythema","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Hypersensitivity","drugRate":"3%","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Factor IX inhibition","drugRate":"3%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Swedish Orphan Biovitrum AB","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=EFTRENONACOG ALFA","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:32:23.281728+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:32:28.776057+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:32:23.351285+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=EFTRENONACOG ALFA","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:32:29.281523+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Coagulation factor IX exogenous protein","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:32:31.391463+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4594598/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:32:31.044637+00:00"}},"allNames":"alprolix","offLabel":[],"synonyms":["eftrenonacog alfa","alprolix","eftrenonacog alfa (genetical recombination)"],"timeline":[{"date":"2016-05-12","type":"positive","source":"DrugCentral","milestone":"EMA approval (Swedish Orphan Biovitrum AB)"}],"aiSummary":"Alprolix is a protein-based medication used to treat Hemophilia A and Hemophilia B, as well as other congenital bleeding disorders. It works by replacing the missing or defective coagulation factor IX in the body, which is necessary for blood clotting.","approvals":[{"date":"2016-05-12","orphan":true,"company":"Swedish Orphan Biovitrum AB","regulator":"EMA"}],"brandName":"Alprolix","ecosystem":[{"indication":"Hereditary factor IX deficiency disease","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Biologic","explanation":"","oneSentence":"","technicalDetail":"Alprolix is a recombinant human coagulation factor IX product, produced through the expression of a human factor IX gene in a mammalian cell line. It is a glycoprotein with a molecular weight of approximately 56 kDa, and has a specific activity of approximately 100 IU/mg."},"commercial":{"revenueYear":2024,"annualRevenue":300,"revenueSource":"Sanofi 20-F FY2024","revenueCurrency":"USD"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5084","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=EFTRENONACOG%20ALFA","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=EFTRENONACOG ALFA","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T10:57:06.348029","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:32:32.611926+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"eftrenonacog alfa","indications":{"approved":[{"name":"Hereditary factor IX deficiency disease","source":"DrugCentral","snomedId":41788008,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04590950","phase":"","title":"Dosage and PD Study of Eftrenonacog-alfa","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2019-12-18","conditions":["Severe Haemophilia B"],"enrollment":15,"completionDate":"2020-03-31"},{"nctId":"NCT03901755","phase":"","title":"An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2019-09-12","conditions":["Hemophilia B"],"enrollment":151,"completionDate":"2024-03-12"},{"nctId":"NCT05856266","phase":"PHASE4","title":"An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa","status":"TERMINATED","sponsor":"Swedish Orphan Biovitrum","startDate":"2023-08-24","conditions":["Hemophilia A","Hemophilia B"],"enrollment":10,"completionDate":"2023-12-06"},{"nctId":"NCT03055611","phase":"","title":"A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2017-05-09","conditions":["Haemophilia A","Haemophilia B"],"enrollment":201,"completionDate":"2022-04-19"},{"nctId":"NCT03655340","phase":"","title":"A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2018-09-12","conditions":["Haemophilia B"],"enrollment":91,"completionDate":"2022-03-16"}],"_emaApprovals":[{"date":"2016-05-12","status":"Authorised","company":"Swedish Orphan Biovitrum AB"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"MMSL":"220196","UNII":"02E00T2QDE","INN_ID":"9660","RXNORM":"1535944","UMLSCUI":"C3818700","chemblId":"CHEMBL4594598","ChEMBL_ID":"CHEMBL4594598","KEGG_DRUG":"D10522","DRUGBANK_ID":"DB11608","SNOMEDCT_US":"718942000","MESH_SUPPLEMENTAL_RECORD_UI":"C000599709"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Swedish Orphan Biovitrum AB","relationship":"Original Developer"}],"publicationCount":15,"therapeuticAreas":["Metabolic"],"_revenueScrapedAt":"2026-03-31 13:40:26.690445+00","biosimilarFilings":[],"originalDeveloper":"Swedish Orphan Biovitrum AB","recentPublications":[{"date":"2024 Jul","pmid":"39101128","title":"Real-world usage and effectiveness of recombinant factor VIII/factor IX Fc in hemophilia A/B: final data from the 24-month, prospective, noninterventional PREVENT study in Germany.","journal":"Research and practice in thrombosis and haemostasis"},{"date":"2024 Feb","pmid":"38333660","title":"Portal vein thrombosis in a patient with severe hemophilia B: A challenging balanced management.","journal":"Clinical case reports"},{"date":"2024 Feb","pmid":"38070040","title":"Matching-Adjusted Indirect Comparison of Recombinant Factor IX Albumin Fusion Protein Versus Recombinant Factor IX Fc Fusion Protein for Weekly Prophylactic Treatment of Hemophilia B.","journal":"Advances in therapy"},{"date":"2023 Aug","pmid":"37720484","title":"Long-term outcomes of prophylaxis with a recombinant factor VIII Fc or recombinant factor IX Fc in patients with hemophilia previously treated on demand.","journal":"Research and practice in thrombosis and haemostasis"},{"date":"2023 Jun","pmid":"37222971","title":"Correction to: Eftrenonacog Alfa: A Review in Haemophilia B.","journal":"Drugs"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Swedish Orphan Biovitrum AB","companyId":"swedish-orphan-biovitrum-ab","modality":"Recombinant protein","firstApprovalDate":"2016","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2016-05-12T00:00:00.000Z","mah":"Swedish Orphan Biovitrum AB","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":2,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:32:32.611926+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}