Veopoz FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 18, 2023.
FDA Approved: Yes (First approved August 18, 2023)
Brand name: Veopoz
Generic name: pozelimab-bbfg
Dosage form: Injection
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: CHAPLE Disease
Veopoz (pozelimab-bbfg) is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease.
- CHAPLE (also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy, or CD55-deficient protein-losing enteropathy) is an ultra-rare hereditary immune disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms. It is driven by an overactivation of the complement system.
- People with CHAPLE are unable to regulate complement activity due to mutations in the CD55 gene. Without proper CD55 regulation, the complement system may attack normal cells, causing damage to blood and lymph vessels.
- Veopoz contains pozelimab-bbfg, which is an IgG4 antibody that binds with high affinity to wild-type and variant human C5. It works to treat CHAPLE by blocking the activity of complement factor C5, a protein involved in complement system activation.
- Veopoz is administered via intravenous infusion then subcutaneous injection. A loading dose is administered by intravenous infusion on day 1, and then the maintenance doses are administered by subcutaneous injection once weekly starting on day 8.
- The Veopoz product label carries a Boxed Warning for meningococcal infections which can be life-threatening and fatal. Patients receiving Veopoz should complete or update meningococcal vaccination for both MenACWY and MenB at least 2 weeks prior to receiving the first dose.
- Warnings and precautions associated with Veopoz include other bacterial infections (including gonococcal infection), systemic hypersensitivity reactions, and immune complex formation.
- Common adverse reactions include upper respiratory tract infection, fracture, urticaria, and alopecia.
Development timeline for Veopoz
Further information
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