The FDA has approved enlicitide, marketed as Lipfendra, as the first oral PCSK9 inhibitor for treating hypercholesterolemia. Unlike existing injectable therapies in this class, this new drug offers a once-daily tablet option to lower LDL cholesterol in adults who require additional reduction beyond diet and maximally tolerated statins. Clinical trials involving over 3,200 patients demonstrated the drug's efficacy and safety profile.
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