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Nuwiq (SIMOCTOCOG ALFA)
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.
At a glance
| Generic name | SIMOCTOCOG ALFA |
|---|---|
| Sponsor | Octapharma AB |
| Modality | Recombinant protein |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2014 |
Approved indications
- Factor VIII deficiency
- Hereditary factor VIII deficiency disease
Common side effects
- Upper respiratory tract infection
- Headache
- Fever
- Cough
- Lower respiratory tract infection
- Rhinitis
- Chills
- Abdominal pain
- Arthralgia
- Pharyngitis
- Diarrhea
- Varicella
Serious adverse events
- Syncope
- Deterioration in neurological function/behavior
- Benign renal neoplasm
- Injection site inflammation
- Injection site pain
- Malaise
- Dyspnea
- Insomnia
- Dizziness
- Tonsillitis
Key clinical trials
- Emicizumab PUPs and Nuwiq ITI Study (PHASE3)
- Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
- A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nuwiq CI brief — competitive landscape report
- Nuwiq updates RSS · CI watch RSS
- Octapharma AB portfolio CI