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FDA Approves Oral PCSK9 Inhibitor for Cholesterol Reduction

The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), an oral medication designed to lower LDL cholesterol. This approval marks the first time an oral PCSK9 inhibitor has received authorization for use in adults with high cholesterol.

07/27/2026 · Washington edition

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WASHINGTON – The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide) for the reduction of low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. This medication represents the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9).

Doctors will prescribe Lipfendra as an addition to diet and exercise regimens. The FDA's decision provides a new treatment option for individuals working to manage their cholesterol levels.

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