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Lipfendra

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health1 hour ago•5 min saved

FDA approves first oral PCSK9 inhibitor to slash LDL cholesterol

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, to be used with diet and existing LDL-lowering therapies in adults with high cholesterol, including inherited forms. In phase 3 trials, Lipfendra reduced LDL cholesterol by about 56%–60% when added to statin therapy, roughly doubling the impact of many statin regimens. The pill offers a convenient alternative to injectable PCSK9 inhibitors and was generally well tolerated, with diarrhea and dizziness as common side effects and similar discontinuation rates to placebo. Merck noted that large cardiovascular-outcome data are still pending, with results expected in 2029.

via Fox News|

#cholesterol #fda-approval #health

health1 hour ago•192 min saved

Merck’s Lipfendra gains FDA nod as first oral PCSK9 inhibitor

Merck’s cholesterol pill Lipfendra (enlicitide) was approved by the FDA, becoming the first oral PCSK9 inhibitor on the market and offering an alternative to injectable cholesterol drugs. The decision was based on two late‑stage trials showing significant LDL‑C reductions across a broad patient group, including those with familial hypercholesterolemia and statin users. The drug could help Merck diversify beyond Keytruda, with analysts forecasting potential tens of billions in peak sales amid competition from injectable PCSK9 drugs like Repatha and Praluent.

via CNN|

#enlicitide #fda #health