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Regeneron Says FDA Extends Approval of Praluent to Treat Children, Teens With Genetic High-Cholesterol
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Regeneron Says FDA Extends Approval of Praluent to Treat Children, Teens With Genetic High-Cholesterol
Mar 11, 2024 5:43 AM

08:28 AM EDT, 03/11/2024 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Monday that the US Food and Drug Administration has extended its approval of Praluent as an adjunct to diet and other cholesterol-lowering therapies to include pediatric patients aged 8 and older with a genetic form of high cholesterol.

The approval to treat children and teens with Praluent (alirocumab) followed a 24-week phase 3 trial of patients aged 8 to 17 with heterozygous familial hypercholesterolemia. Patients who received Praluent every four weeks had 31% lower LDL-C than placebo at 24 weeks, the company said.

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