Evolocumab gains FDA approval for patients aged 10 years and older with heterozygous FH
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Amgen announced that the FDA has approved evolocumab as an adjunct to diet and other LDL-lowering therapies for the treatment of heterozygous familial hypercholesterolemia in pediatric patients aged 10 years and older.
According to a company press release, the approval of evolocumab (Repatha) is based on data form the HAUSER-RCT phase 3b study that evaluated the efficacy and safety of evolocumab in patients aged 10 to 17 years with heterozygous familial hypercholesterolemia (FH).
As Healio previously reported, pediatric patients with heterozygous FH who received monthly evolocumab injections experienced greater reductions in LDL and other lipid variables at 24 weeks compared with placebo, according to data presented at the 2020 European Society of Cardiology Congress.
"The approval of Repatha for pediatric 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," David M. Reese, MD, executive vice president of research and development at Amgen, said in the release.
According to the release, evolocumab was also approved as an adjunct to other LDL-lowering therapies for the treatment of homozygous FH for pediatric patients.
Moreover, evolocumab had previously been approved for treatment in patients with homozygous FH aged 13 years and older and is now available for patients aged 10 years and older, according to the release
"As pediatric 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," Katherine A. Wilemon, founder and CEO of the FH Foundation, said in the release.
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