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On March 22, 2024, the U.S. Food and Drug Administration approved expanded indications for bempedoic acid (Nectol) and bempedoic acid and ezetimibe (Nexlisette) tablets for both primary and secondary prevention of cardiovascular disease (CV). Indications for increased LDL-C lowering were included. According to an announcement from the manufacturer Esperion, there is a risk of ).

Expanding indications support the use of bempedoic acid alone, in combination with ezetimibe as monotherapy, or in combination with statins, and is also indicated for the treatment of primary hyperlipidemia, either alone or in addition to statin therapy. included.

With these expanded indications, the once-daily orally administered two drugs become the only LDL-C-lowering non-statin drugs indicated for primary CVD prevention, the company said. The label expands the non-statin drug’s potential patient population to approximately 70 million U.S. adults who have or are at risk for hyperlipidemia-related CVD, according to Esperion. .

“These approvals expand the availability of our highly effective medicines for primary prevention patients…” Sheldon Koenig, Esperion’s president and chief executive officer, said in the announcement. “These approvals also eliminate the requirement for statin use and allow patients to take NEXLETOL or NEXLIZET with or without a statin, greatly reducing prescribing restrictions that previously existed. We believe these approvals position NEXLETOL and NEXLIZET as first-line non-statin drugs in the cardiovascular risk reduction treatment paradigm.”

A widely anticipated and anticipated indication for CV risk reduction, we evaluated the effects of bempedoic acid on CV outcomes in 14,000 participants with CVD on statin therapy or at high risk of CVD. Based on the results of the CLEAR Outcomes clinical trial. Unable to tolerate or unwilling to take medication. Participants were followed for a median of 3.4 years. Investigators are New England Medical JournalParticipants treated with bempedoic acid experienced a relative risk reduction of:

• 15% For MACE-3 (CV death, non-fatal stroke, or non-fatal myocardial infarction)
• 27% For non-fatal MI
• 19% for coronary artery revascularization
• 39% Evaluation of MACE-3 in primary prevention participants

The researchers also reported a 20% reduction in LDL-C and a 22% reduction in hsCRP. Additionally, no increases in blood sugar levels were observed in participants who received bempedoic acid versus those who received a placebo, Esperion said.

Results from the CLEAR Outcomes prespecified analysis, published in January 2024, assessed the impact of bempedoic acid versus placebo on the overall incidence of CV events during the study, with treatment with the drug leading to a 4-point MACE score. Three-point MACE was associated with a 20% relative risk reduction, compared with 17% for MI, 31% for MI, and 22% for coronary revascularization.

“NEXLETOL and NEXLIZET are once-daily, easily available oral medications that reduce LDL-C and cardiovascular risk, but without the side effects most commonly seen with statins. It is also the first oral non-statin LDL-C lowering drug approved by the FDA to reduce the risk of CV events in both patients. We believe this will be a game-changer for both…” Koenig said.

Biography

Bempedoic acid was initially approved by the FDA in February 2020 as an add-on therapy to maximum-tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. it was done. At the time, the label stated that the effects of bempedoic acid on CV morbidity and mortality had not yet been confirmed.

The first indication expansion in December 2023 updated the indication to include the treatment of primary hyperlipidemia in eligible individuals as a modifier of the existing approved population. Importantly, language specifying maximum-tolerated statin therapy as a prerequisite for treatment with bempedoic acid was removed from the label, as well as a use restriction stating the undetermined impact on CV morbidity and mortality. That’s what happened.

Source: U.S. FDA approves broad new labeling for Nestletol and Nexlisette to prevent heart attacks and cardiovascular procedures in patients for primary and secondary prevention, regardless of statin use. news release. Esperion Therapeutics. March 22, 2024. Accessed March 24, 2024. https://www.esperion.com/news-releases/news-release-details/us-fda-approves-broad-new-labels-nexletolr-and-nexlizetr-prevent