FDA approves Regeneron's Praluent for treating pediatric HeFH patients aged 8+, based on a Phase 3 trial demonstrating 31% lower LDL-C.
Regeneron's Praluent (alirocumab) has received FDA approval to treat pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH), in addition to diet and other LDL-C lowering therapies. The approval is based on a Phase 3 trial, which showed 31% lower LDL-C in patients who received Praluent every four weeks at 24 weeks compared to placebo. Praluent is the first PCSK9 inhibitor approved by the FDA for treating HeFH.
March 11, 2024
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