FDA approves add-on therapy for patients with genetic form of severely high cholesterol - Drug Information Update

U.S. Food and Drug Administration sent this bulletin at 04/01/2021 03:32 PM EDT

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA approves add-on therapy for patients with genetic form of severely high cholesterol

FDA has approved Praluent (alirocumab) injection for adult patients with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Praluent is not intended to be used alone but instead added to other treatments for HoFH.

Common side effects of Praluent are nasopharyngitis (cold), injection site reactions, and influenza. Serious hypersensitivity (allergic) reactions have occurred among people taking Praluent.

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