Evinacumab: Difference between revisions
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| tradename = Evkeeza |
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Revision as of 17:29, 31 March 2021
| 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 |
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| Routes of administration | Intravenous |
| ATC code |
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| 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).[1][2]
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.[2]
Evinacumab binds to the angiopoietin-like protein 3 (ANGPTL3).[2] ANGPTL3 slows the function of certain enzymes that break down fats in the body.[2] Evinacumab blocks ANGPTL3, allowing faster break down of fats that lead to high cholesterol.[2] Evinacumab was approved for medical use in the United States in February 2021.[2][3]
History
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).[2] In the trial, 43 participants received 15 mg/kg of evinacumab every four weeks and 22 participants received the placebo.[2] Participants were taking other lipid-lowering therapies as well.[2]
The primary measure of effectiveness was the percent change in low-density lipoprotein (LDL-C) from the beginning of treatment to week 24.[2] At week 24, participants receiving evinacumab had an average 47% decrease in LDL-C while participants on the placebo had an average 2% increase.[2]
The U.S. Food and Drug Administration (FDA) granted the application for evinacumab orphan drug, breakthrough therapy, and priority review designations.[2] The FDA granted approval of Evkeeza to Regeneron Pharmaceuticals, Inc.[2]
References
- ^ a b https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761181s000lbl.pdf
- ^ a b c d e f g h i j k l m n "FDA approves add-on therapy for patients with genetic form of severely". U.S. Food and Drug Administration (FDA). 11 February 2021. Retrieved 12 February 2021.
This article incorporates text from this source, which is in the public domain.
- ^ "FDA Approves First-in-class Evkeeza (evinacumab-dgnb) for Patients with Ultra-rare Inherited Form of High Cholesterol" (Press release). Regeneron Pharmaceuticals. 11 February 2021. Retrieved 12 February 2021 – via PR Newswire.
Further reading
- Dewey FE, Gusarova V, Dunbar RL, O'Dushlaine C, Schurmann C, Gottesman O, et al. (July 2017). "Genetic and Pharmacologic Inactivation of ANGPTL3 and Cardiovascular Disease". N Engl J Med. 377 (3): 211–221. doi:10.1056/NEJMoa1612790. PMC 5800308. PMID 28538136.
External links
- "Evinacumab". Drug Information Portal. U.S. National Library of Medicine.
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