Evinacumab
Other Lipid Modifying Agents
Sold as Evkeeza
- Drug class
- Other Lipid Modifying Agents
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 3
Overview
Evinacumab is an active pharmaceutical ingredient in the Other Lipid Modifying Agents group (C10AX). 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 29, 2026 |
| EU European Union | EMA | 1 | February 26, 2026 |
| CA Canada | Health Canada | 1 | August 27, 2025 |
GBUnited Kingdom· MHRA
1 product
Uses
Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and paediatric patients aged 6 months and older with homozygous familial hypercholesterolaemia (HoFH).
How to take
EUEuropean Union· EMA
1 product
Uses
Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and paediatric patients aged 6 months and older with homozygous familial hypercholesterolaemia (HoFH).
How to take
CACanada· Health Canada
1 product
Uses
EVKEEZA® (evinacumab for injection) is indicated as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients 6 months of age and older with homozygous familial hypercholesterolemia (HoFH).
The effects of Evkeeza on cardiovascular morbidity and mortality have not been determined. 1 Pediatrics Pediatrics (6 months to 17 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Evkeeza in pediatric patients 5 to 17 years of age have been established.
3 Pharmacokinetics and 14 CLINICAL TRIALS).
Pediatrics (< 6 months):
The safety and efficacy of Evkeeza in pediatric patients less than 6 months of age has not been established; therefore, Health Canada has not authorized an indication for pediatric patients less than 6 months of age. 3 Pharmacokinetics and 14 CLINICAL TRIALS).
Sources & citations
- [1]MHRA (UK) · PLGB477930003 · revised May 29, 2026
- [2]European Medicines Agency · EMEA/H/C/005449 · revised February 26, 2026
- [3]Health Canada (DPD) · 02541769 · revised August 27, 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.