Evinacumab
Monoclonal antibody
- US DailyMed: Evinacumab
administration
- C10AX17 (WHO)
- 1446419-85-7
- DB15354
- none
- T8B2ORP1DW
- D11753
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]
References
- ^ "Details for: Evkeeza". Health Canada. 21 November 2023. Retrieved 3 March 2024.
- ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]". Health Canada. 22 December 2023. Retrieved 3 January 2024.
- ^ "Summary Basis of Decision (SBD) for Evkeeza". Health Canada. 8 February 2024. Retrieved 24 February 2024.
- ^ a b "Evkeeza- evinacumab injection, solution, concentrate". DailyMed. Retrieved 14 September 2021.
- ^ 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. - ^ a b c "Drug Trial Snapshot: Evkeeza". U.S. Food and Drug Administration. 22 November 2022. Retrieved 23 November 2022. This article incorporates text from this source, which is in the public domain.
- ^ a b c d "Evkeeza EPAR". European Medicines Agency (EMA). 21 April 2021. Retrieved 18 December 2021.
- ^ "Evkeeza Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ "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". U.S. Food and Drug Administration (FDA). 11 March 2021. Retrieved 13 September 2021.
- ^ a b 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. 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
- 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.
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| Cholesterol absorption inhibitors, NPC1L1 | |
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| Bile acid sequestrants/resins (LDL) |
| Statins (HMG-CoA reductase, LDL) | |
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| Niacin and derivatives (HDL and LDL) | |
| MTTP inhibitors (VLDL) | |
| ATP citrate lyase inhibitors (LDL) | |
| Thyromimetics (VLDL) |
| PPAR agonists (LDL) |
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| CETP inhibitors (HDL) | |||||
| PCSK9 inhibitors (LDL) | |||||
| ANGPTL3 inhibitors (LDL/HDL) |
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- #WHO-EM
- ‡Withdrawn from market
- Clinical trials:
- †Phase III
- §Never to phase III
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