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Idelvion (ALBUTREPENONACOG ALFA)
Idelvion (Albutrepennonacog alfa) is a recombinant coagulation factor IX-FVIII complex, originally developed by CSL Behring GmbH and currently owned by the same company. It is used to treat Hereditary factor IX deficiency disease. Idelvion is administered via injection and is not a small molecule, but rather a protein-based therapy. It is not off-patent and its commercial status is patented. Key safety considerations include potential for thromboembolic events and hypersensitivity reactions.
At a glance
| Generic name | ALBUTREPENONACOG ALFA |
|---|---|
| Sponsor | CSL Behring GmbH |
| Modality | Recombinant protein |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2016 |
Approved indications
- Hereditary factor IX deficiency disease
Common side effects
- Headache
- Dizziness
- Hypersensitivity
- Rash
- Eczema
Serious adverse events
- Factor IX inhibitor development
Key clinical trials
- Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy (PHASE3)
- Observatory of Patients With Haemophilia B Treated by IdElvion®
- A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B (PHASE3)
- ATHN 2: Factor Switching Study
- The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients (PHASE4)
- A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B (PHASE1,PHASE2)
- A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B (PHASE2,PHASE3)
- A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B (PHASE3)
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:
- Idelvion CI brief — competitive landscape report
- Idelvion updates RSS · CI watch RSS
- CSL Behring GmbH portfolio CI