FDA approves bempedoic acid/ezetimibe for LDL lowering in ASCVD, HeFH
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Esperion Therapeutics announced that a medication combining bempedoic acid and ezetimibe to lower LDL in adults with heterozygous familial hypercholesterolemia or established atherosclerotic CVD has been approved by the FDA.
This treatment (Nexlizet) is currently indicated as an adjunct to diet and maximally tolerated statin therapy, according to a press release from the company.
The FDA approval of bempedoic acid and ezetimibe comes nearly 1 week after the approval of bempedoic acid itself (Nexletol, Esperion Therapeutics) for reducing LDL as an adjunct to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia (HeFH) or established ASCVD, as Healio previously reported.
“Nexlizet provides significant additional LDL-C lowering for adult patients with ASCVD or HeFH when added to maximally tolerated statin medicine, including those patients for whom maximally tolerated statin may be no statin at all,” Christie M. Ballantyne, MD, professor and chief of cardiology at Baylor College of Medicine in Houston and chairman of the phase 3 executive committee for Esperion, said in the release.
The medication lowers LDL with complementary mechanisms of action that inhibit cholesterol synthesis in the liver and absorption by the intestine, according to the release.
“The appeal of this drug is we see millions of people in America who just refuse to take statins because they get myalgia,” Cardiology Today Editorial Board Member Steven E. Nissen, MD, MACC, chief academic officer of the Heart and Vascular Institute at Cleveland Clinic, told Healio. “We needed to have a drug that we could give these patients that would work well at lowering LDL effectively but would not cause muscle symptoms. Bempedoic acid does that, but the LDL reduction is moderate. Now if you combine it with ezetimibe, you get about double the LDL reduction because these two drugs work independently.”
This drug can also be administered once per day, according to the release.
“It ... has the conventional, oral, once daily administration, which can prove beneficial to patients struggling to meet their cholesterol goals with the currently available statin options in their daily regimen,” Ballantyne said in the release.
This FDA approval was based on results from a phase 3 CLEAR CV outcomes trial. As Healio previously reported, the combination of bempedoic acid and ezetimibe lowered LDL to a greater degree than placebo or either agent alone.
“In the prevention clinic at the Cleveland Clinic, patients get referred to us from all over who have tried every statin, and they just can’t tolerate statins, or if they do tolerate statins, they don’t tolerate high-enough doses to get their LDLs down,” Nissen said in an interview. “We really haven’t had great options for them. This idea of getting them a single pill that contains ezetimibe and bempedoic acid in getting some 40% or so reduction in LDL I think is going to be welcomed by the cardiovascular, endocrine and even primary care communities. This is an important addition to the therapeutic armamentarium that we’ve been waiting for, for quite a number of years.”
This combination medicine may help many patients who have either ASCVD or HeFH, according to the release.
“The approval of Nexlizet underscores Esperion’s commitment to providing patients and their health care providers with innovative nonstatin medicines that fit into their everyday routines to lower elevated levels of bad cholesterol in adult patients with ASCVD or HeFH on maximally tolerated statins,” Tim M. Mayleben, president and CEO of Esperion, said in the release. “This is the first nonstatin combination medicine ever approved for lowering LDL-C.”
The drug will be commercially available in July, according to the release. – by Darlene Dobkowski
For more information:
Steven E. Nissen, MD, MACC, can be reached at nissens@ccf.org.
Disclosures: Nissen reports that he is the study chairman for the ongoing CV outcome trial with bempedoic acid sponsored by Esperion. Ballantyne is a chairman of the phase 3 executive committee for Esperion. Mayleben is an employee of Esperion.
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