Phase III ODYSSEY HoFH trial of Praluent meets primary endpoint in homozygous familial hypercholesterolemia
The trial met its primary endpoint, with Praluent-treated patients experiencing a 36% reduction in LDL-C at week 12 compared to placebo (27% reduction Praluent, 9% increase placebo, p<0.0001). At the same time point, compared to baseline praluent-treated patients also experienced that average ldl-c levels decreased by 72 mg dl compared to placebo (63 mg dl reduction praluent, 9 mg dl increase placebo). more than half (57%) reduced their ldl-c by at least 30% and more than a quarter (27%) reduced their ldl-c by at least half, compared to 4% and 0% for placebo, respectively (p="0.0010" and p="0.0017)." no serious aes, permanent treatment discontinuations or deaths were reported during the double-blind treatment period. during the double-blind treatment period, the ae that occurred in at least 5% of patients, and more commonly with praluent, was diarrhea (7% praluent, 0% placebo). aes that occurred in at least 5% of patients, and more commonly with placebo, were upper respiratory tract infection (4% praluent, 8% placebo) and headache (4% praluent, 8% placebo). regeneron plans to submit these data as the basis of regulatory submissions with the fda in the second quarter of 2020. data were presented at the american college of cardiology's annual scientific session together with world congress of cardiology (acc.20).></0.0001).>
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The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Evkeeza, from Regeneron, intended for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).Evkeeza will be available as concentrate for solution for infusion (150 mg/ml).
The FDA has approved Praluent (alirocumab), from Regeneron, as an adjunct to other low-density lipoprotein cholesterol (LDL-C)-lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
Regeneron Pharmaceuticals, Inc. announced that the FDA has approved Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).