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VEOPOZ (POZELIMAB-BBFG)
VEOPOZ (generic name: POZELIMAB-BBFG) is a Complement Inhibitor [EPC] drug developed by REGENERON PHARMACEUTICALS. It is currently FDA-approved for CD55-deficient PLE (CHAPLE disease).
Pozelimab-bbfg blocks C5 cleavage, preventing C5a and C5b formation and inhibiting terminal complement activation.
Pozelimab is a complement C5 inhibitor, classified as an antibody inhibitor. It is being studied in a clinical trial (NCT07142343) for the treatment of CHAPLE Disease in pediatric participants aged 1 to 5 years.
At a glance
| Generic name | POZELIMAB-BBFG |
|---|---|
| Sponsor | REGENERON PHARMACEUTICALS |
| Drug class | Complement Inhibitor [EPC] |
| Target | C5 |
| Therapeutic area | Other |
| Phase | FDA-approved |
Mechanism of action
Pozelimab-bbfg is a monoclonal antibody that targets the complement protein C5. By blocking the cleavage of C5, it prevents the formation of C5a and C5b, which are key components in the terminal complement pathway. This inhibition stops the formation of the membrane-attack complex, thus preventing cell lysis.
Approved indications
- CD55-deficient PLE (CHAPLE disease)
Boxed warnings
- WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update meningococcal vaccination (for serogroups A, C, W and Y, and serogroup B) at least 2 weeks prior to administering the first dose of VEOPOZ, unless the risks of delaying therapy outweigh the risk of developing a meningococcal infection. Follow the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. Patients receiving VEOPOZ are at increased risk for invasive disease caused by N. meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected [see Warnings and Precautions (5.1) ] . WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. ( 5.1 ) Complete or update meningococcal vaccination at least 2 weeks prior to administering the first dose of VEOPOZ, unless the risks of delaying therapy outweigh the risks of developing meningococcal infection. Follow the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. ( 5.1 ) Patients receiving VEOPOZ are at increased risk for invasive disease caused by N. meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. ( 5.1 )
Common side effects
- upper respiratory tract infection
- fracture
- urticaria
- alopecia
Drug interactions
- Intravenous Immunoglobulin
Key clinical trials
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 |
|---|---|
| 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:
- VEOPOZ CI brief — competitive landscape report
- VEOPOZ updates RSS · CI watch RSS
- REGENERON PHARMACEUTICALS portfolio CI
Frequently asked questions about VEOPOZ
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Related
- Drug class: All Complement Inhibitor [EPC] drugs
- Target: All drugs targeting C5
- Manufacturer: REGENERON PHARMACEUTICALS — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for CD55-deficient PLE (CHAPLE disease)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing