United States-based Amgen (NASDAQ:AMGN) announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for its Repatha (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies to treat paediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia(HeFH)to decrease LDL-C.
Repatha received approval based on the HAUSER-RCT Phase 3b study assessing the safety and efficacy of the product in paediatric patients, 10-17 years of age, with HeFH. The product lowered LDL-C by mean 38% from baseline compared to placebo, meeting its primary endpoint. The FDA also approved the product as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger paediatric patients.
David M Reese, MD, EVP of Research and Development at Amgen, said, 'The approval of Repatha for paediatric patients with FH represents a much-needed adjunct treatment option for these children with genetically high cholesterol who are unable to manage their high LDL-C with other lipid-lowering agents alone. This milestone further reinforces the safety profile of Repatha and aligns with Amgen's commitment to addressing the unmet needs of the high-risk cardiovascular community.'
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