Merck's oral PCSK9 inhibitor LIPFENDRA approved by the US FDA.

On July 16, Merck announced that the FDA approved the oral PCSK9 inhibitor LIPFENDRA for the treatment of adult hypercholesterolemia, including heterozygous familial hypercholesterolemia. This drug is the first oral PCSK9 inhibitor approved by the FDA. Phase III CORALreef Lipids trial showed that after 24 weeks of treatment, LIPFENDRA reduced low-density lipoprotein cholesterol by 56% compared to placebo; in the CORALreef HeFH trial, the reduction was 59%. The company stated that cardiovascular outcome studies are still ongoing and the drug has not been confirmed to lower the risk of cardiovascular events.