FDA Approves Updated Label for Bempedoic Acid, Ezetimibe Tablets
The update also removed the maximally tolerated qualifier for statin use and the statement that said morbidity and mortality was not yet determined.
The FDA has approved an updated low-density lipoprotein (LDL)-cholesterol lowering indication for bempedoic acid (Nexletol, Esperion) and ezetimibe (Nexlizet, Esperion), to add to treatment for primary hyperlipidemia among individuals that were previously approved for usage. The update also removed the maximally tolerated qualifier for statin use and the statement that said morbidity and mortality was not yet determined.
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“We are pleased that the FDA has approved these modifications to our current indications for Nexletol and Nexlizet, which reinforce the proven efficacy and safety of these treatments,” said Sheldon Koenig, MBA, President and CEO of Esperion Therapeutics, in a press release.
The press release noted that the changes are effective immediately to aid the FDA’s goal of synchronizing drug labels.
Bempedoic acid and ezetimibe tablets were previously approved in addition to diet and statin therapy to treat primary hyperlipidemia in individuals with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease that need LDL-C lowering, according to study authors.
The safety and efficacy of bempedoic acid and ezetimibe tablets were assessed in the CLEAR clinical research program that intends to reach over 70 million individuals that have or are at risk for CVD due to elevated LDL-C.
The researchers found that bempedoic acid should not be used in individuals that have a hypersensitivity to the ezetimibe tablets. The study authors also noted that individuals with hypersensitivity could experience anaphylaxis, angioedema, rash, and urticaria.
The most commonly reported adverse reactions for bempedoic included upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. Adverse events that were reported when taking ezetimibe included upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity fatigue, and influenza.
Despite the current label updates, the study authors noted that they do not impact the full changes that were submitted for approval in June of 2023, on the cardiovascular risk reduction indications. However, the study authors noted that the updates could be granted approval in the early months of 2024.
Reference
U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet. Esperion. News release. December 13, 2023. Accessed December 14, 2023. https://www.esperion.com/news-releases/news-release-details/us-fda-updates-ldl-c-lowering-indication-esperions-nexletolr.
