FDA approves evolocumab In patients aged 10 and older with familial hypercholesterolemia
Approval for heterozygous familial hypercholesterolemia is based on results of the HAUSER-RCT which found monthly treatment with evolocumab, as an adjunct to diet and other lipid-lowering therapies, reduced LDL-C by 38% from baseline vs placebo (95% CI: 45%, 31%; p < 0.0001).
Source:
FDA
SPS commentary:
The FDA has also approved evolocumab for the treatment of homozygous familial hypercholesterolemia in patients aged 10 and older. In the UK, evolocumab for this indication is currently restricted to patients aged 12 years and older.