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FDA approves Lipfendra as first oral PCSK9 inhibitor for cholesterol
Fox News • • business
Key Points:
- The FDA has approved Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor for adults with high cholesterol, including inherited forms, as an add-on to diet and other LDL-lowering therapies.
- Lipfendra works by blocking PCSK9, a protein that increases bad cholesterol (LDL) by preventing the recycling of LDL receptors in the liver, and has shown a 56% to 60% LDL cholesterol reduction in phase 3 trials when combined with statins.
- The medication was generally well-tolerated, with common side effects including diarrhea and dizziness, and serious side effects occurring at rates similar to placebo.
- PCSK9 inhibitors like Lipfendra offer an alternative for patients who have very high cholesterol, inherited cholesterol disorders, or adverse reactions to statins, and the oral form may improve adherence compared to injectable options like Repatha and Praluent.
- Further research is underway to assess whether Lipfendra reduces cardiovascular events such as heart attacks and strokes, with results from a large clinical trial expected in 2029.
