{"id":"lonoctocog-alfa","rwe":[],"tags":[{"label":"Biologic","category":"modality"},{"label":"Active","category":"status"},{"label":"Hereditary factor VIII deficiency disease","category":"indication"},{"label":"CSL Behring GmbH","category":"company"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Factor VIII inhibition (in previously untreated patients)","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypersensitivity","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"CSL Behring GmbH","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=LONOCTOCOG ALFA","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:03:57.785335+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Lonoctocog Alfa","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:04:06.320907+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:04:04.935539+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:03:57.810415+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LONOCTOCOG ALFA","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:04:05.671417+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Coagulation factor VIII exogenous protein","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:04:06.320544+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4594603/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:04:06.218844+00:00"}},"allNames":"afstyla","offLabel":[],"synonyms":["lonoctocog alfa","afstyla"],"timeline":[{"date":"2017-01-04","type":"positive","source":"DrugCentral","milestone":"EMA approval (CSL Behring GmbH)"},{"date":"2017-09-27","type":"positive","source":"DrugCentral","milestone":"PMDA approval (CSL Behring KK)"}],"approvals":[{"date":"2017-01-04","orphan":false,"company":"CSL Behring GmbH","regulator":"EMA"},{"date":"2017-09-27","orphan":false,"company":"CSL Behring KK","regulator":"PMDA"}],"brandName":"Afstyla","ecosystem":[{"indication":"Hereditary factor VIII deficiency disease","otherDrugs":[{"name":"desmopressin","slug":"desmopressin","company":"Ferring Pharms Inc"},{"name":"emicizumab","slug":"emicizumab","company":"Genentech Inc"},{"name":"vasopressin","slug":"vasopressin","company":"Parke Davis"}],"globalPrevalence":null}],"mechanism":{"modality":"Biologic","explanation":"","oneSentence":"","technicalDetail":"Afstyla is a recombinant factor VIII replacement therapy, which means it is a genetically engineered version of the natural factor VIII protein. It is designed to mimic the natural protein's structure and function, allowing it to interact with other proteins in the blood and facilitate proper clotting."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Factor_VIII_(medication)","title":"Factor VIII (medication)","extract":"Factor VIII, an essential blood coagulation protein, is used as a medication to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII. Certain preparations may also be used in those with von Willebrand's disease. It is given by slow injection into a vein.","wiki_history":"==History==\nThis transfer of a plasma byproduct into the blood stream of a hemophiliac often led to the transmission of diseases such as HIV and hepatitis before purification methods were improved. In the early 1990s, pharmaceutical companies began to produce recombinant synthesized factor products, which now prevent nearly all forms of disease transmission during replacement therapy.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nvon Willebrand Factor/Coagulation Factor VIII Complex (Human) (sold under the brand name Wilate) was approved for medical use in the United States in 2009.\n\n=== Economics ===\nThe cost of Factor VIII and similar clotting factors has been described as \"highly expensive\".  They are so expensive that gene therapy for haemophilia might be less expensive, especially for people with severe hemophilia."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5265","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LONOCTOCOG ALFA","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Factor_VIII_(medication)","fields":["history","overview"],"source":"Wikipedia"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T14:09:03.993619","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:04:08.438445+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"lonoctocog alfa","indications":{"approved":[{"name":"Hereditary factor VIII deficiency disease","source":"DrugCentral","snomedId":28293008,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"2017-01-04","status":"Authorised","company":"CSL Behring GmbH"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"MMSL":"242309","NDDF":"016883","UNII":"VQ723R7O8R","INN_ID":"9834","RXNORM":"1796377","UMLSCUI":"C4257011","chemblId":"CHEMBL4594603","ChEMBL_ID":"CHEMBL4594603","KEGG_DRUG":"D10818","DRUGBANK_ID":"DB13998","SNOMEDCT_US":"1012961000168107"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"CSL Behring GmbH","relationship":"Original Developer"},{"period":"2017","companyName":"CSL Behring KK","relationship":"PMDA Licensee"}],"publicationCount":11,"therapeuticAreas":["Hematology"],"biosimilarFilings":[],"originalDeveloper":"CSL Behring GmbH","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"CSL Behring GmbH","companyId":"csl-behring-gmbh","modality":"Recombinant protein","firstApprovalDate":"2017","aiSummary":"Afstyla is a recombinant factor VIII protein used to treat conditions such as Hemophilia A, Congenital Bleeding Disorder, and Kidney Disease. It works by replacing the missing or defective coagulation factor VIII in the body to help prevent bleeding.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2017-01-04T00:00:00.000Z","mah":"CSL Behring GmbH","brand_name_local":"","application_number":""},{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2017-09-27T00:00:00.000Z","mah":"CSL Behring KK","brand_name_local":null,"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":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:04:08.438445+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":false,"score":2}}