Quick answers
- What is Pozelimab used for?
- The FDA-approved label (Veopoz, Regeneron Pharmaceuticals, Inc., December 4, 2025) says: “VEOPOZ is indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. VEOPOZ is a complement inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pozelimab have a boxed warning?
- Yes. The FDA label for Veopoz has a boxed warning (“WARNING: SERIOUS MENINGOCOCCAL INFECTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pozelimab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pozelimab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pozelimab?
- 1 company lists prescription products of Pozelimab in the FDA NDC Directory, including Regeneron Pharmaceuticals, Inc..
What Pozelimab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VEOPOZ is indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. VEOPOZ is a complement inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.
— FDA label: Veopoz, Regeneron Pharmaceuticals, Inc., effective December 4, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous · Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Veopoz |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Regeneron Pharmaceuticals, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761339 VEOPOZ | Regeneron Pharmaceuticals | August 18, 2023 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2663945, 2663952 |
|---|---|
| SPL set ID of the quoted label | a8d6f10e-9430-450a-a3dd-b538f9b2a308 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761339 |
| Active ingredients (FDA) | POZELIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Veopoz, Regeneron Pharmaceuticals, Inc., effective December 4, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →