🫀 A new chapter in cholesterol treatment has begun.

The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first once-daily oral medication that inhibits PCSK9, offering a new option to help lower LDL cholesterol, often called "bad" cholesterol.

For years, PCSK9 inhibitors have been available only as injectable medicines. Lipfendra changes that by becoming the first FDA-approved oral PCSK9 inhibitor, providing eligible adults with another way to reduce LDL cholesterol alongside a heart-healthy diet and other cholesterol-lowering treatments, including statins when appropriate.

LDL cholesterol plays a major role in the buildup of plaque inside arteries, increasing the risk of heart attack, stroke, and other cardiovascular diseases. By blocking the PCSK9 protein, Lipfendra helps the liver remove more LDL cholesterol from the bloodstream, leading to lower cholesterol levels.

The FDA approved the medication for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), based on results from Merck's Phase 3 CORALreef clinical development program, which demonstrated significant reductions in LDL cholesterol.

While Lipfendra is not a replacement for healthy lifestyle habits or existing cholesterol therapies, its approval expands the options available to healthcare providers and patients who need additional LDL cholesterol lowering.

As with any prescription medicine, treatment decisions should always be made with a healthcare professional to determine the most appropriate therapy for each individual.

Read our full article to learn how Lipfendra works, who may benefit from it, and why this FDA approval is an important step forward in cholesterol management.