Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Repatha (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of paediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C.

HeFH is an inherited, genetic condition with a prevalence of one in 250 people worldwide. High levels of LDL-C starting at birth accelerate the development of atherosclerotic cardiovascular disease, leading to an overall increased risk of cardiovascular events, including heart attack and other vascular conditions, at an earlier age. Children with familial hypercholesterolemia (FH) can be normal weight, have a good diet, exercise enough and still have high LDL-C.

"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," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "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."

"As paediatric FH is an under-recognized condition that can lead to premature coronary artery disease, it's critically important to have additional treatments that can significantly lower cholesterol," said Katherine Wilemon, founder and chief executive officer at The FH Foundation.

The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger paediatric patients. Repatha was already approved for treatment in HoFH patients aged 13 and older and is now available as a treatment for patients aged 10 and older.