Amgen's Repatha Scores FDA Nod For Pediatric Patients Over 10 Years With Inherited Heart Disease

The FDA has approved Amgen Inc's AMGN Repatha (evolocumab) as an adjunct for pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C.
Repatha is approved as an add-on to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies.
Related Content: Amgen's Repatha Improves Plaque Stability In Heart Patients
HeFH is an inherited genetic condition characterized by high levels of LDL-C starting at birth that accelerate the development of atherosclerotic cardiovascular disease at an earlier age.
The approval is based on the HAUSER-RCT Phase 3b study. Monthly treatment with Repatha reduced LDL-C by a mean of 38% from baseline compared to placebo, meeting its primary endpoint.
Repatha had improved secondary lipid parameters from baseline compared to the placebo.
The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies to treat homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients. Repatha was already approved for HoFH patients aged 13 and older.
Related content: Benzinga's Full FDA Calendar.
Price Action: AMGN stock closed 0.67% lower at $213.61 on Friday.

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