Sebelipase Alfa
Enzymes
Sold as Kanuma
- Drug class
- Enzymes
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 3
Overview
Sebelipase Alfa is an active pharmaceutical ingredient in the Enzymes group (A16AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| EU European Union | EMA | 1 | March 24, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
1 product
Uses
KANUMA is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.
How to take
EUEuropean Union· EMA
1 product
Uses
KANUMA is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.
How to take
CACanada· Health Canada
1 product
Uses
KANUMA® (sebelipase alfa for injection) is indicated for the treatment of infants, children and adults diagnosed with lysosomal acid lipase (LAL) deficiency. Kanuma treatment should be supervised by a healthcare professional experienced in the management of patients with LAL deficiency, other metabolic disorders, or chronic liver diseases.
Kanuma should be administered by a trained healthcare professional who can manage medical emergencies. 1 Pediatrics Pediatrics (0-18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Kanuma in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use.
(see Section 14: Clinical Trials) Administration of Kanuma to infants with confirmed multiple-organ failure should be at the discretion of the treating physician. 2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of Kanuma in patients older than 65 years have not been evaluated and no alternative dosage regimens can be recommended for these patients.
Sources & citations
- [1]MHRA (UK) · PLGB311870017 · revised May 15, 2026
- [2]European Medicines Agency · EMEA/H/C/004004 · revised March 24, 2026
- [3]Health Canada (DPD) · 02469596 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.