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aBLA Filing Intelligence & Biosimilar Opportunity

Evkeeza

Evinacumab-Dgnb
Antihyperlipidemic
Injection Solution

Homozygous familial hypercholesterolemia produces extreme LDL levels from birth, and patients often respond poorly to therapies that depend on a working LDL receptor. Evkeeza (evinacumab) offered a route around that limitation.

Unlike statins, PCSK9 inhibitors, and most other lipid therapies, Evkeeza works independently of LDL receptor activity, which makes it effective even in receptor-negative patients. The intravenous antibody is given every four weeks as add-on therapy and was the first ANGPTL3 inhibitor approved.

Evkeeza has since expanded into younger pediatric age groups, and as a biologic it carries twelve years of regulatory exclusivity from approval with no biosimilar competition. It is the benchmark ANGPTL3 agent for lipid trial planning.

Approval Date
02-Nov-21
Data Exclusivity Expiry
02-Nov-25
Market Exclusivity Expiry
02-Nov-33
Commercial snapshot

Market performance & projections

Revenue ($M)
222
CAGR (%)
9.23%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
262
2027
286
2028
302
2029
316
2030
329
2031
346
2032
360
Molecule profile

Details & specifications

Molecule
Evinacumab-Dgnb
Innovator
REGENERON PHARMACEUTICALS
Dosage Form
Injection Solution
Strength
345 mg/2.3 mL, 1200 mg/8 mL
Therapeutic Category
Antihyperlipidemic
Usage
To treat homozygous familial hypercholesterolemia
Good to know

Frequently asked questions

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Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.

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