Quick answers
- What is Spesolimab used for?
- The FDA-approved label (Spevigo, Boehringer Ingelheim Pharmaceuticals, Inc., April 8, 2026) says: “SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Spesolimab have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Spesolimab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Spesolimab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Spesolimab?
- 2 companies list prescription products of Spesolimab in the FDA NDC Directory, including LEO Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc..
What Spesolimab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
— FDA label: Spevigo, Boehringer Ingelheim Pharmaceuticals, Inc., effective April 8, 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.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Spevigo |
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.
- LEO Pharma Inc.3 products
- Boehringer Ingelheim Pharmaceuticals, Inc.3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761244 SPEVIGO | Boehringer Ingelheim Pharmaceuticals Inc | September 1, 2022 | 4, latest October 21, 2025 2025: Labeling · 2025: Labeling · 2025: Efficacy |
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Spevigo, Boehringer Ingelheim Pharmaceuticals, Inc., effective April 8, 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 →