Phase III ELIPSE HoFH trial results of REGN 1500 met primary endpoint in homozygous familial hypercholesterolemia.- Regeneron Pharma
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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).