FDA approval of oral PCSK9 inhibitor Lipfendra

The U.S. Food and Drug Administration (FDA) has approved enlicitide, marketed under the brand name Lipfendra, as the first oral PCSK9 inhibitor. This once-daily pill provides an alternative to the injectable versions of this class of medication, which have previously been limited by high costs and the requirement for injections.

Clinical data from Phase III studies, including CORALreef Lipidsund and CORALreef HeFH, indicate that the medication reduces LDL cholesterol by 56% to 59% compared to a placebo. It also demonstrates significant reductions in non-HDL cholesterol, apolipoprotein B, and lipoprotein(a).

Lipfendra is intended for adults with atherosclerotic cardiovascular disease, including those who require additional therapy alongside existing medications or those unable to tolerate statins. Medical professionals note that the treatment requires strict adherence, specifically taking the tablet on an empty stomach within a designated time window before eating. The estimated annual list price is approximately $3,800, which is lower than the roughly $6,000 annual cost associated with injectable alternatives.