Regeneron: the FDA approves the use of Evkeeza for children aged 5 to 11 – 03/22/2023 at 13:52


(AOF) – The American laboratory Regeneron announces that the FDA, the American authority in charge of health products, extends the authorization of its product Evkeeza to children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH), a hereditary disease characterized by extremely high levels of low-density lipoprotein cholesterol. Evkeeza was originally approved in February 2021 as an adjunct to other lipid-lowering therapies in people aged 12 and older with HoFH.

Familial hypercholesterolemia is an extremely rare inherited disease that affects approximately 1,300 people in the United States and is the most severe form of familial hypercholesterolemia (FH). It occurs when two copies of the genes responsible for familial hypercholesterolemia are inherited, one from each parent.

People with familial hypercholesterolemia are more likely to develop lung cancer, while those with high cholesterol are at risk for premature atherosclerotic disease and heart attacks as early as adolescence.

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Loss of speed in European research

European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.



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