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(rFVIII)"],"timeline":[{"date":"2014-07-22","type":"positive","source":"DrugCentral","milestone":"EMA approval (Octapharma AB)"},{"date":"2021-01-22","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Fujimoto Pharmaceutical Corporation)"}],"aiSummary":"Nuwiq (SIMOCTOCOG ALFA) is a recombinant human coagulation factor VIII product developed by Octapharma AB. It is used to treat patients with Factor VIII deficiency, also known as Hemophilia A, a genetic disorder that impairs the body's ability to form blood clots. Nuwiq is administered via injection and is designed to replace the deficient clotting factor in the body. The commercial status of Nuwiq is patented, and it is approved for use in patients with hereditary Factor VIII deficiency disease. Key safety considerations include the risk of developing inhibitors, which can reduce the effectiveness of the treatment.","approvals":[{"date":"2014-07-22","orphan":false,"company":"Octapharma AB","regulator":"EMA"},{"date":"2021-01-22","orphan":false,"company":"FUJIMOTO PHARMACEUTICAL CORPORATION","regulator":"PMDA"}],"brandName":"Nuwiq","ecosystem":[{"indication":"Factor VIII deficiency","otherDrugs":[],"globalPrevalence":null},{"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":"Nuwiq is a recombinant human coagulation factor VIII product that is produced through a process of fermentation and purification. It has a similar amino acid sequence to native human factor VIII and is designed to mimic the natural protein's function in the body."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5228","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=SIMOCTOCOG%20ALFA","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SIMOCTOCOG ALFA","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T15:39:47.264141","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:37:01.001902+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"simoctocog alfa","indications":{"approved":[{"name":"Factor VIII 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