Amgen’s Repatha (evolocumab) Receives the US FDA’s Approval for the Treatment of Heterozygous Familial Hypercholesterolemia

Shots:

• The approval is based on the P-IIIb HAUSER-RCT study evaluating the safety & efficacy of Repatha (420mg, SC) vs PBO in a ratio (2:1) in pediatric patients aged 10 – 17yrs. with HeFH for 24wks.
• The trial met its 1EPs i.e., 38% reduction in LDL-C from baseline, patients treated with Repatha had improved secondary lipid parameters from baseline including (35% & 27%) reduction in non-HDL-C & total cholesterol along with 32% reduction in ApoB @24wks., no new safety risks were observed
• Repatha is a mAb that inhibits PCSK9 & has been approved as an adjunct to diet & other LDL-C lowering therapies for HeFH. The therapy has previously been approved in patients aged ≥13 for the same indication

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