FDA approves Lipfendra, the first oral PCSK9 inhibitor pill

The U.S. Food and Drug Administration (FDA) has approved enlicitide, marketed under the brand name Lipfendra, as a new oral treatment to lower LDL cholesterol. This medication represents a significant development in the class of PCSK9 inhibitors, which have previously only been available via injection.

Clinical trials demonstrated that Lipfendra can reduce LDL cholesterol by 56% to 59% compared to a placebo. The once-daily pill is designed to be used by adults with atherosclerotic cardiovascular disease, including those who cannot tolerate statins due to side effects or those who require additional cholesterol-lowering therapy alongside existing medications.

While previous PCSK9 inhibitors have been highly effective, they have been limited by high costs and the requirement for injections. Lipfendra is expected to have an estimated list price of approximately $3,800 per year, which is lower than the roughly $6,000 annual cost associated with injectable alternatives.