Merck has announced FDA approval for enlicitide, the first FDA-approved once-daily oral pill designed to lower low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with the inherited genetic disorder heterozygous familial hypercholesterolemia (HeFH).
The oral PCSK9 inhibitor is intended to be used in conjunction with diet and exercise to effectively reduce LDL-C, commonly known as ‘bad cholesterol’, in adults with hypercholesterolemia or HeFH.
Basis for approval
Approval follows two phase 3 trials from the CORALreef clinical programme, which demonstrated that enlicitide significantly reduced LDL-C levels compared with placebo.
Specifically, treatment with enlicitide reduced LDL-C levels by 56% at week 24 in the CORALreef Lipids trial and by 59% at week 24 in the CORALreef HeFH trial.
Dr Ann Marie Navar, Associate Professor of Medicine, Division of Cardiology, UT Southwestern Medical Center and lead author of the CORALreef Lipids study, said:
“In two phase 3 trials, [enlicitide] led to impressive reductions in LDL-C. Now, for the first time, patients have an oral PCSK9 inhibitor for LDL lowering.”
Cardiovascular implications
Evidence from cardiovascular outcomes trials has shown that lowering LDL-C reduces the risk of major adverse cardiovascular events in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors alongside statin therapy.
However, the effects of enlicitide on cardiovascular morbidity and mortality are not yet known and are currently being assessed in an ongoing trial.
Katherine Wilemon, CEO, Family Heart Foundation, said:
“One of the greatest opportunities to help manage the risk of ASCVD lies in the timely identification and appropriate treatment of risk factors, such as LDL-C…”
“We are encouraged by the approval of a new oral PCSK9 inhibitor option for adults who need additional LDL-C lowering.”
The approval marks a new development in cholesterol management, providing another potential option for patients who require additional LDL-C lowering strategies.
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