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FDA Approves Evkeeza for Kids With Ultra-Rare Cholesterol Disorder

FDA Approves Evkeeza for Kids With Ultra-Rare Cholesterol Disorder

The FDA has expanded Regeneron’s Evkeeza (evinacumab-dgnb) approval to include treatment of children aged five years old to 11 suffering from homozygous familial hypercholesterolemia (HoFH), an ultra-rare form of high cholesterol.

Evkeeza, an angiopoietin-like protein 3 inhibitor, was originally approved in February 2021 as an adjunct to other lipid-lowering drugs in patients 12 years and older with HoFH.

The approval was supported by a pediatric study of Evkeeza in patients previously treated with lipid-lowering therapies that demonstrated an average reduction of 48 percent in low-density lipoprotein cholesterol (LDL-C) at week 24.

HoFH, the most severe manifestation of familial hypercholesterolemia, afflicts an estimated 1,300 people in the U.S., and is caused by two copies of the FH-inducing gene being inherited from each parent which results in dangerous levels of LDL-C.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

March 23, 2023


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