FDA approves add-on indication for Repatha

The US Food and Drug Administration has approved a new indication for Repatha (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce low-density lipoprotein cholesterol (LDL-C.

Marketed by US biotech giant Amgen (Nasdaq: AMGN), Repatha generated second-quarter 2021 sales of $286 million in its current currently approved indications, a year-on-year increase of 43%.

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.