Lipfendra oral PCSK9 inhibitor receives FDA approval

The US FDA has approved Lipfendra (Enlicitid), the first oral PCSK9 inhibitor taken as a daily tablet. This medication marks a shift in cholesterol treatment by providing an alternative to the injections typically required for PCSK9 inhibitors.

A pooled analysis of two Phase III studies, CORALreef Lipidsund and CORALreef HeFH, demonstrated that Enlicitid significantly reduces concentrations of LDL cholesterol, non-HDL cholesterol, apolipoprotein B, and lipoprotein(a) across various cardiovascular risk categories. Clinical data shows the drug lowers LDL cholesterol by 56% to 59% compared to a placebo.

The treatment is intended as an additional option that can be combined with existing cholesterol-lowering therapies. However, medical professionals note that strict adherence to a daily routine is required, including taking the tablet on an empty stomach within a specific time window before eating.