Michael H. Davidson
The FDA has approved bempedoic acid for reducing LDL as an adjunct to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia or established atherosclerotic CVD, according to the agency’s website and an alert from Esperion Therapeutics.
Bempedoic acid (Nexletol, Esperion Therapeutics), a once-daily therapy that is designed to work in the liver to inhibit cholesterol biosynthesis, has been shown in CLEAR Wisdom and other studies to reduce LDL in high-risk patients beyond levels achieved with diet and maximally tolerated statin therapy, as Healio previously reported.
In CLEAR Wisdom, a phase 3 study of 779 patients, treatment with bempedoic acid 180 mg once daily reduced LDL at week 12 — the primary endpoint — by 17.4% compared with placebo (P < .001).
“This approval delivers upon a commitment we’ve made to millions of patients for a new treatment alternative if they struggle with bad cholesterol and have ASCVD or heterozygous familial hypercholesterolemia,” Tim Mayleben, president and CEO of Esperion Therapeutics, said in a statement emailed to Healio. “Even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals. Today’s approval provides them with a new medicine to go along with a healthy diet. We express our sincere gratitude to all of the patients and physicians who put their confidence in Esperion’s team of lipid experts.”
“The LDL-C lowering for bempedoic acid is modest at 18% compared with placebo in combination with statins, but the efficacy is up to 25% in patients who are not taking a statin due to intolerance,” Cardiology Today Editorial Board Member Michael H. Davidson MD, FACC, FACP, FNLA, professor and director of the Lipid Clinic at The University of Chicago Pritzker School of Medicine, said in an interview. “The combination tablet with ezetimibe, which is also expected to be FDA-approved soon, will provide about a 40% LDL-C reduction, which could be an excellent option for patients with statin intolerance. My hope is that payers will respond favorably to this novel therapy and allow reimbursement for the patients with statin intolerance who have high CV risk (ie, diabetes) but do not have established ASCVD or heterozygous FH.”
The effect of bempedoic acid on CV outcomes has not been determined, according to a statement on the drug’s label.
“The CLEAR Outcomes study of bempedoic acid is fully enrolled and, once complete, demonstrating a CV benefit will lead to a monotherapy indication for all patients with elevated LDL-C,” Davidson said in an interview. “I am a strong believer in the LDL hypothesis, which means that LDL-C is causal for atherosclerosis, and therefore the earlier the treatment initiation and the lower the achieved LDL-C, the better. So, I will be using bempedoic acid in my patients with statin intolerance, but recognize that some clinicians may want to wait until the results of the ongoing CV outcomes trial.” – by Erik Swain
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Michael H. Davidson, MD, FACC, FACP, FNLA, can be reached at email@example.com; Twitter: @mdavidsonmd.
Disclosure: Davidson reports he consults for Esperion. Mayleben is an employee of Esperion.