FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol First oral PCSK9 inhibitor provides an additional treatment option for adults with hypercholesterolemia

https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol?utm_campaign=42504259-FnB%2C%20Cosmetics%2C%20Med%20Dev%2C%20Drugs%20%7C%20Newsfeed%20%7C%20Global%20%7C%202026&utm_medium=email&_hsenc=p2ANqtz-_s-MT3cfSv-c6YF_we_1DNE9RTvQBnpwszN5SRJz8BpKuB4iWecy2M79RhPaI1Mq5R-1RIN8NxycqGjB8U3WNBHlXotw&_hsmi=430311558&utm_content=429969268&utm_source=hs_email FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol FDA has approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor for adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). Previously available only as injectable therapies, PCSK9 inhibitors now have an oral treatment option that provides significant LDL cholesterol reduction when used alongside diet, exercise, and existing therapies. The approval reflects continued innovation in chronic disease treatment and FDA's commitment to expanding patient access to new therapeutic options.