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Amgen (AMGN) Repatha Gets FDA Nod for Expanded Use in Kids

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Amgen (AMGN - Free Report) announced that the FDA has approved its PCSK9 inhibitor, Repatha for different forms of familial hypercholesterolemia (FH) in pediatric patients.

The first approval is for Repatha as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C. In addition, the FDA also approved Repatha for the homozygous form of familial hypercholesterolemia (HoFH) for pediatric patients 10 to 12 years of age. Repatha is already approved for HoFH in patients aged 13 and older.

Amgen’s stock has declined 7.1% this year so far compared with a decrease of 1.3% for the industry.

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The FDA approval for the HeFH indication, the more common type of FH, was based on data from the HAUSER-RCT study, which showed that Repatha led to a significant reduction in LDL-C or “bad” cholesterol in pediatric patients, 10-17 years of age.

FH is an inherited disease that causes high levels of LDL-C at an early age, which can result in premature coronary artery disease that can further increase the risk of heart attack and other cardiovascular events in children. The approval of Repatha for pediatric patients with FH opens up a new treatment option for kids with genetically high cholesterol, which is not being managed well by other lipid-lowering agents alone.

Repatha is a key top-line driver for Amgen. The drug generated sales of $572 million in the first half of 2021, representing an increase of 33% year over year. as higher volumes made up for lower prices. The approval for expanded use in pediatric patients may drive sales higher in the future quarters.

Another PCSK9 inhibitor available is Sanofi (SNY - Free Report) /Regeneron’s (REGN - Free Report) Praluent. Alnylam/Novartis’ (NVS - Free Report) Inclisiran, which was approved by the trade name of Leqvio in the EU in December 2020 for the treatment of hypercholesterolemia or mixed dyslipidemia, can also pose competition to Repatha. The candidate is under review in the United States

Amgen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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