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Review
. 2021 Jun;81(9):1101-1105.
doi: 10.1007/s40265-021-01516-y. Epub 2021 May 18.

Evinacumab: First Approval

Anthony Markham  1
Affiliations
Review

Evinacumab: First Approval

Anthony Markham. Drugs. 2021 Jun.

Abstract

The recombinant human monoclonal antibody evinacumab (evinacumab-dgnb, EVKEEZA™) is an angiopoietin-like protein three (ANGPTL3) inhibitor that has been developed by Regeneron Pharmaceuticals for the treatment of homozygous familial hypercholesterolaemia (HoFH), refractory hypercholesterolemia (both familial and non-familial) and severe hypertriglyceridaemia. Based on the results of the phase III ELIPSE HoFH trial, evinacumab was recently approved in the USA as an adjunct to other LDL-C lowering therapies for the treatment of adult and paediatric patients aged 12 years and older with HoFH, and has received a positive opinion in the EU. This article summarizes the milestones in the development of evinacumab leading to this first approval for HoFH.

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References

    1. Regeneron Pharmaceuticals. FDA approves first-in-class EVKEEZATM (evinacumab-dgnb) for patients with ultra-rare inherited form of high cholesterol [media release]. 11 Feb 2021. https://investor.regeneron.com .
    1. Regeneron Pharmaceuticals. Regeneron pipeline. 2021. https://www.regeneron.com/pipeline . Accessed 30 Mar 2021.
    1. Gaudet D, Gipe DA, Pordy R, et al. ANGPTL3 inhibition in homozygous familial hypercholesterolemia. N Engl J Med. 2017;377(3):296–7. - DOI
    1. Raal FJ, Rosenson RS, Reeskamp LF, et al. Evinacumab for homozygous familial hypercholesterolemia. N Engl J Med. 2020;383(8):711–20. - DOI
    1. Regeneron Pharmaceuticals. EVKEEZA™ (evinacumab-dgnb) injection: US prescribing information. 2021. https://www.regeneron.com/sites/default/files/Evkeeza_PI.pdf . Accessed 15 Feb 2021.

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