Regeneron data could set up first-in-class approval in lipid-lowering indication

Regeneron's evinacumab could give certain hypercholesterolemia patients a new treatment option, with an FDA submission looming based on new results from a Phase III trial evaluating the first-in-class therapy as an add-on to existing treatments.

Among 65 patients with homozygous familial hypercholesterolemia (HoFH), the inhibitor of ANGPTL3 cut LDL cholesterol by 47% vs. an increase of 2% for placebo at week 24, meeting the Phase III ELIPSE HoFH trial's primary endpoint. From a baseline average of 255 mg/DL, the therapy led to LDL cholesterol levels below 100 mg/dL in 47% of patients vs. 23% for placebo (nominal p=0.0203)...