Evinacumab

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Evinacumab
Monoclonal antibody
Type Whole antibody
Source Human
Target Angiopoietin-like 3 (ANGPTL3)
Clinical data
Trade names Evkeeza
Other namesREGN1500, evinacumab-dgnb
AHFS/Drugs.com Evkeeza
License data
Routes of
administration 		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
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]

Contents

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

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]

References

  1. ↑ "Details for: Evkeeza". Health Canada . 21 November 2023. Retrieved 3 March 2024.
  2. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]". Health Canada . 22 December 2023. Retrieved 3 January 2024.
  3. ↑ "Summary Basis of Decision (SBD) for Evkeeza". Health Canada . 8 February 2024. Retrieved 24 February 2024.
  4. 1 2 "Evkeeza- evinacumab injection, solution, concentrate". DailyMed. Retrieved 14 September 2021.
  5. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 "FDA approves add-on therapy for patients with genetic form of severely". U.S. Food and Drug Administration (FDA). 11 February 2021. Archived from the original on 11 February 2021. Retrieved 12 February 2021.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  6. 1 2 3 "Drug Trial Snapshot: Evkeeza". U.S. Food and Drug Administration. 22 November 2022. Retrieved 23 November 2022.PD-icon.svg This article incorporates text from this source, which is in the public domain.
  7. 1 2 3 4 "Evkeeza EPAR". European Medicines Agency (EMA). 21 April 2021. Retrieved 18 December 2021.
  8. ↑ "Evkeeza Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  9. ↑ "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.
  10. ↑ "Drug Approval Package: Evkeeza". U.S. Food and Drug Administration (FDA). 11 March 2021. Archived from the original on 23 March 2021. Retrieved 13 September 2021.
  11. 1 2 Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  12. ↑ "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.

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