Chemistry: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 |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| 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).[2][3][4]
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.[3]
Evinacumab binds to the angiopoietin-like protein 3 (ANGPTL3).[3] ANGPTL3 slows the function of certain enzymes that break down fats in the body.[3] Evinacumab blocks ANGPTL3, allowing faster break down of fats that lead to high cholesterol.[3] Evinacumab was approved for medical use in the United States in February 2021.[3][7][8] The U.S. Food and Drug Administration considers it to be a first-in-class medication.[9]
History
Regeneron invented evinacumab.[10]
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).[3] In the trial, 43 participants received 15 mg/kg of evinacumab every four weeks and 22 participants received the placebo.[3] Participants were taking other lipid-lowering therapies as well.[3] The trial was conducted in the United States, Italy, France, Greece, Netherlands, Austria, Canada, Australia, New Zealand, Ukraine, South Africa, and Japan.[4]
The primary measure of effectiveness was the percent change in low-density lipoprotein (LDL-C) from the beginning of treatment to week 24.[3] At week 24, participants receiving evinacumab had an average 47% decrease in LDL-C while participants on the placebo had an average 2% increase.[3]
The U.S. Food and Drug Administration (FDA) granted the application for evinacumab orphan drug, breakthrough therapy, and priority review designations.[3][9] The FDA granted approval of Evkeeza to Regeneron Pharmaceuticals, Inc.[3]
Society and culture
Legal status
On 22 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).[5] The applicant for this medicinal product is Regeneron Ireland Designated Activity Company (DAC).[5] Evinacumab was approved for medical use in the European Union in June 2021.[5]
References
- ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22"]. 22 December 2023. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2023-12-22.html.
- ↑ 2.0 2.1 "Evkeeza- evinacumab injection, solution, concentrate". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=73412138-6d8f-4ea6-bb72-a740190470ff.
- ↑ 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 3.11 3.12 3.13 "FDA approves add-on therapy for patients with genetic form of severely". 11 February 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-add-therapy-patients-genetic-form-severely-high-cholesterol.
This article incorporates text from this source, which is in the public domain.
- ↑ 4.0 4.1 4.2 "Drug Trial Snapshot: Evkeeza". 22 November 2022. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-evkeeza. This article incorporates text from this source, which is in the public domain.
- ↑ 5.0 5.1 5.2 5.3 "Evkeeza EPAR". 21 April 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/evkeeza.
- ↑ "Evkeeza Product information". https://ec.europa.eu/health/documents/community-register/html/h1551.htm.
- ↑ "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.
- ↑ "Drug Approval Package: Evkeeza". 11 March 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761181Orig1s000TOC.cfm.
- ↑ 9.0 9.1 (PDF) Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (Report). 13 May 2022. https://www.fda.gov/media/155227/download. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
- ↑ "FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol". Regeneron Pharmaceuticals Inc. (Press release). Retrieved 30 August 2021.
Further reading
- "Genetic and Pharmacologic Inactivation of ANGPTL3 and Cardiovascular Disease". N Engl J Med 377 (3): 211–221. July 2017. doi:10.1056/NEJMoa1612790. PMID 28538136.
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