Elosulfase Alfa
Enzymes
Sold as VIMIZIM
- Drug class
- Enzymes
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 4
- Products on record
- 4
- FDA reports (12 mo)
- 355
Overview
Elosulfase 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 |
|---|---|---|---|
| US United States | FDA | 1 | October 30, 2025 |
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| EU European Union | EMA | 1 | October 23, 2025 |
| CA Canada | Health Canada | 1 | July 30, 2025 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE VIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). VIMIZIM is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
( 1 )
How to take
GBUnited Kingdom· MHRA
1 product
Uses
Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
How to take
EUEuropean Union· EMA
1 product
Uses
Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
How to take
CACanada· Health Canada
1 product
Uses
25 Vimizim (elosulfase alfa) Product Monograph Page 3 of 29 PrVimizim® (elosulfase alfa) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Intravenous Infusion Concentrate 1 mg/mL Sterile solution 5 mg/5 mL There are no clinically relevant nonmedicinal ingredients.
For a complete listing of nonmedicinal ingredients see Dosage Forms, Composition and Packaging section. DESCRIPTION Vimizim is a formulation of elosulfase alfa, which is a purified human enzyme (N- acetylgalactosamine-6-sulfatase, GALNS) produced by recombinant DNA technology in a Chinese hamster ovary cell line.
Human GALNS is a hydrolytic lysosomal glycosaminoglycan- specific enzyme that hydrolyzes sulfate from either galactose-6-sulfate or N-acetyl- galactosamine-6-sulfate on the non-reducing ends of the glycosaminoglycans keratan sulfate (KS) and chondroitin-6-sulfate (C6S).
Sources & citations
- [1]FDA DailyMed · 0caa2565-12b2-0a… · revised October 30, 2025 [PDF]
- [2]MHRA (UK) · PLGB458140007 · revised May 15, 2026
- [3]European Medicines Agency · EMEA/H/C/002779 · revised October 23, 2025
- [4]Health Canada (DPD) · 02427184 · revised July 30, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
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.