Bempedoic Acid/Ezetimibe Receives Historic FDA Approval


The non-statin, fixed-dose combination therapy received approval less than one week after bempedoic acid received approval for treatment of HeFH.

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Bempedoic acid and ezetimibe tablet (NEXLIZET), a non-statin, fixed-dose combination therapy, has received approval from the US Food and Drug Administration as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

With approval coming less than a week after Esperion Therapeutics received approval for bempedoic acid, the once-daily, oral combination tablet becomes the first non-statin, LDL-C lowering combination ever approved by the FDA, according to a statement from Esperion.

“Now, you have an option where you have 2 medicines in a single pill that neither 1 includes a statin and you're getting over 30% LDL reduction with that,” said Christie Ballantyne, chief of cardiology at Baylor College of Medicine and chairman of Esperion’s Phase 3 Executive Committee, said in an exclusive interview with HCPLive. “So this would be a benefit for high-risk individuals who need further LDL reductions.”

According to the prescribing information, the approved therapy is a combination of bempedoic acid 180 mg and ezetimibe 10 mg. The FDA recommends bempedoic acid/ezetimibe be taken once-daily, with or without food, and, if coadministering with bile acid sequestrants, administer at least 2 hours before or at least 4 hours after bile acid sequestrants.

Similarly to bempedoic acid's prescribing information, the FDA warns the therapy was associated with increased rates of hyperuricemia and tendon rupture. The FDA also recommends avoiding concomitant use of the combination therapy with simvastatin greater than 20 mg and pravastatin greater than 40 mg. Additionally, the administration warns the mechanism of action may cause fetal harm in pregnant women and breastfeeding is not recommended with bempedoic acid/ezetimibe fixed dose combination tablet.

The statement from Esperion highlighted results of the 12-week phase 3 clinical trial that indicated patients receiving bempedoic acid and ezetimibe tablet saw a 38% reduction on background maximally tolerated statin therapy compared to placebo therapy. Data from this trial also showed the therapy had the ability to decrease hsCRP by 35% from baseline compared to placebo.

“The approval of NEXLIZET underscores Esperion’s commitment to providing patients and their healthcare providers with innovative non-statin 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," said Tim M. Mayleben, president and chief executive officer of Esperion, in the aforementioned statement.

Esperion expects both bempedoic acid and ezetimibe (Nexlizet) and bempedoic acid (Nexletol) to be available in the US by March 30 via prescription only.

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