Quick answers
- What is Pegcetacoplan used for?
- The FDA-approved label (Empaveli, Apellis Pharmaceuticals, Inc., August 21, 2026) says: “EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria and the loss of kidney function. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pegcetacoplan have a boxed warning?
- Yes. The FDA label for Empaveli has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pegcetacoplan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pegcetacoplan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pegcetacoplan?
- 1 company lists prescription products of Pegcetacoplan in the FDA NDC Directory, including Apellis Pharmaceuticals, Inc..
What Pegcetacoplan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria and the loss of kidney function. …
— FDA label: Empaveli, Apellis Pharmaceuticals, Inc., effective August 21, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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. Read it on the full label →
1 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Apellis Pharmaceuticals, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215014 EMPAVELI | Apellis Pharms | May 14, 2021 | 7, latest August 20, 2026 2026: Efficacy · 2025: Efficacy · 2025: Labeling |
| NDA217171 SYFOVRE | Apellis Pharms | February 17, 2023 | 3, latest March 27, 2025 2025: Manufacturing (CMC) · 2024: Labeling · 2023: Labeling |
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) | 2557386, 2557391, 2630847, 2630853 |
|---|---|
| SPL set ID of the quoted label | c23d89e9-b00b-4520-e053-2995a90a95af |
| FDA labels (SPL) | 2 |
| FDA applications | NDA215014, NDA217171 |
| Active ingredients (FDA) | PEGCETACOPLAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Empaveli, Apellis Pharmaceuticals, Inc., effective August 21, 2026; 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 →