Once-daily LDL cholesterol-smashing pill gets FDA approval

FDA approved Lipfendra (enlicitide), a first-in-class oral PCSK9 inhibitor pill, after late-stage trials demonstrated it lowered LDL cholesterol by an average of nearly 60% in patients with hypercholesterolemia—addressing a gap where 70% of patients on existing therapies remain undertreated due to injection aversion and access barriers.

The trials were conducted on people with hypercholesterolemia; effectiveness in other populations has not been detailed.