Evinacumab

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Evinacumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetAngiopoietin-like 3 (ANGPTL3)
Clinical data
Trade namesEvkeeza
Other namesREGN1500, evinacumab-dgnb
AHFS/Drugs.comEvkeeza
License data
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6480H9992N1716O2042S46
Molar mass146083.95 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][4][5]

Regeneron invented evinacumab using the company's VelocImmune® technology, a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human monoclonal antibodies.[6]

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]

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).[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.[3]

References

  1. ^ a b "Evkeeza- evinacumab injection, solution, concentrate". DailyMed. Retrieved 14 September 2021.
  2. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ a b "Evkeeza EPAR". European Medicines Agency (EMA). 21 April 2021. Retrieved 18 December 2021.
  4. ^ "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.
  5. ^ "Drug Approval Package: Evkeeza". U.S. Food and Drug Administration (FDA). 11 March 2021. Retrieved 13 September 2021.
  6. ^ "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". investor.regeneron.com. Retrieved 2021-08-30.
  7. ^ a b "Evkeeza: Pending EC decision". European Medicines Agency. 23 April 2021. Retrieved 23 April 2021.

Further reading

External links

  • "Evinacumab". Drug Information Portal. U.S. National Library of Medicine.