Monoclonal antibody | |
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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 |
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Routes of administration | Intravenous |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
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]
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]
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]