Evinacumab: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Changes resulting from any comments received during the peer review process were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

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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 to treat adult and paediatric patients ≥12 years and older with HoFH, and is under regulatory review in the EU. This article summarizes the milestones in the development of evinacumab leading to this first approval for HoFH.

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