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Evinacumab
Monoclonal antibody
Type	Whole antibody
Source	Human
Target	Angiopoietin-like 3 (ANGPTL3)
Clinical data
Trade names	Evkeeza
Other names	REGN1500, evinacumab-dgnb
AHFS/Drugs.com	Evkeeza
License data	US DailyMed: Evinacumab;
Routes of; administration	Intravenous
ATC code	C10AX17 (WHO) ;
Legal status
Legal status	CA: ℞-only; US: ℞-only; EU: Rx-only;
Identifiers
CAS Number	1446419-85-7;
DrugBank	DB15354;
ChemSpider	none;
UNII	T8B2ORP1DW;
KEGG	D11753;
Chemical and physical data
Formula	C6480H9992N1716O2042S46
Molar mass	146083.95 g·mol−1

Evinacumab, sold under the brand name Evkeeza, is a monoclonal antibody medication for the treatment of homozygous familial hypercholesterolemia (HoFH).^[4]^[5]^[6]

Common side effects include nasopharyngitis (cold), influenza-like illness, dizziness, rhinorrhea (runny nose), and nausea. Serious hypersensitivity (allergic) reactions have occurred in the Evkeeza clinical trials.^[5]

Evinacumab binds to the angiopoietin-like protein 3 (ANGPTL3).^[5] ANGPTL3 slows the function of certain enzymes that break down fats in the body.^[5] Evinacumab blocks ANGPTL3, allowing faster break down of fats that lead to high cholesterol.^[5] Evinacumab was approved for medical use in the United States in February 2021.^[5]^[9]^[10] The U.S. Food and Drug Administration considers it to be a first-in-class medication.^[11]

History

Regeneron invented evinacumab.^[12]

The effectiveness and safety of evinacumab were evaluated in a double-blind, randomized, placebo-controlled, 24-week trial enrolling 65 participants with homozygous familial hypercholesterolemia (HoFH).^[5] In the trial, 43 participants received 15 mg/kg of evinacumab every four weeks and 22 participants received the placebo.^[5] Participants were taking other lipid-lowering therapies as well.^[5] The trial was conducted in the United States, Italy, France, Greece, Netherlands, Austria, Canada, Australia, New Zealand, Ukraine, South Africa, and Japan.^[6]

The primary measure of effectiveness was the percent change in low-density lipoprotein (LDL-C) from the beginning of treatment to week 24.^[5] At week 24, participants receiving evinacumab had an average 47% decrease in LDL-C while participants on the placebo had an average 2% increase.^[5]

The U.S. Food and Drug Administration (FDA) granted the application for evinacumab orphan drug, breakthrough therapy, and priority review designations.^[5]^[11] The FDA granted approval of Evkeeza to Regeneron Pharmaceuticals, Inc.^[5]

Society and culture

Legal status

In April 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Evkeeza, intended for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).^[7] The applicant for this medicinal product is Regeneron Ireland Designated Activity Company (DAC).^[7] Evinacumab was approved for medical use in the European Union in June 2021.^[7]