24 August 2021 - Approval based on HAUSER RCT demonstrating a significant reduction in low-density lipoprotein cholesterol.
Amgen today announced that the U.S. FDA has approved Repatha (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol lowering therapies for the treatment of paediatric patients aged 10 years and older with heterozygous familial hypercholesterolaemia to reduce low-density lipoprotein cholesterol.