FDA approves Praluent for homozygous familial hypercholesterolemia.- Regeneron
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Regeneron Pharmaceuticals, Inc. announced positive results from a Phase III trial evaluating Evkeeza (evinacumab) in children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).
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.