FDA grants license extension of alirocumab (Praluent) as an adjunct for treatment of adults with homozygous familial hypercholesterolaemia
Approval was based on a 12-week RCT which demonstrated a 27% decrease in LDL-C from baseline in the 45 patients treated with alirocumab, in addition to other lipid lowering therapies, vs a 9% increase with placebo.
Source:
US Food and Drug Administration