– New label expands number of treatable patients in the U.S. to nearly 70 million –
– First LDL-C lowering non-statin indicated for primary prevention patients –
– Approval based on positive CLEAR results data and reflects highly differentiated product profile –
– Received positive feedback from CHMP. European cardiovascular (CV) risk reduction label decision expected in Q2 2024 –
– Conference call and webcast, Monday, March 25th at 8 a.m. ET –
ANN ARBOR, Mich., March 22, 2024 (Globe Newswire) — Esperion (NASDAQ: ESPR) today announced that the U.S. Food and Drug Administration (FDA) has approved extensive new label extensions for NEXLETOL.® (Bempedoic acid) tablets and Nexlysit® (Bempedoic acid and ezetimibe) tablets based on positive CLEAR outcome data, including cardiovascular risk reduction and extended LDL-C lowering indications in both primary and secondary prevention patients. Additionally, the enhanced labeling supports the use of NEXLETOL and NEXLIZET alone or in combination with statins. These include new indications for primary hyperlipidemia, either alone or in combination with statins, making it the only LDL-C-lowering non-statin drug indicated for primary prevention patients.
“We are pleased to receive approval for this long-awaited expansion in the U.S.,” said Sheldon Koenig, President and CEO. It will happen,” he said. “Importantly, these approvals expand the availability of our highly effective medicines for primary prevention patients and for patients who are at high risk for a cardiovascular event but have not yet had a cardiovascular event. These approvals also eliminate the requirement for statin use and allow patients to take NEXLETOL or NEXLIZET with or without a statin, significantly reducing prescribing restrictions that previously existed. We believe these approvals position NEXLETOL and NEXLIZET as non-statins. selected first Within the cardiovascular risk reduction treatment paradigm. ”
“We are excited about these significantly expanded labels and look forward to bringing lifesaving medicines to millions more patients. In anticipation of these approvals, our company has significantly strengthened its sales force, developed a powerful suite of new promotional materials, created bold new consumer campaigns, strengthened patient support programs, and partnered with payers to ensure improved patient access. We have continued to cooperate with
“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 it will be equally transformational for our company, and we expect to see a meaningful shift in sales as a result. Thank you to the entire Esperion team for their unwavering dedication to patients and for getting us to this point. I have great confidence in our future success.”
The Company’s pending label expansion in Europe remains on track and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 21, 2024. The Company expects a final decision by the European Medicines Agency to be made in the second quarter of 2024. 2024.
The U.S. approval of NEXLIZET and NEXLETOL for cardiovascular risk reduction and LDL-C lowering was based on data from the CLEAR Outcomes trial published in the New England Journal of Medicine in March 2023. We evaluated the effect of NEXLETOL on outcomes. Approximately 14,000 patients have or are at high risk for cardiovascular disease. Patients were followed for a median of 3.4 years, and bempedoic acid (found in NEXLETOL and NEXLIZET) was generally safe and well-tolerated. In this study, bempedoic acid reduced LDL-C by 20%, hsCRP by 22%, and did not increase blood glucose levels compared to placebo. Patients who received bempedoic acid in the trial experienced a relative risk reduction of:
- 15% for MACE-3 (death due to cardiovascular disease, non-fatal stroke, or non-fatal myocardial infarction)
- 27% for non-fatal myocardial infarction
- 19% for coronary revascularization;
- MACE-3 rate in primary prevention patients is 39%
Conference call and webcast information
Esperion will host a conference call and webcast on Monday, March 25 at 8 a.m. ET to discuss these FDA approvals and new and expanded indications for NEXLETOL and NEXLIZET. Click here to join the conference call.
The live webcast can also be accessed through the Investors and Media section of the Esperion website. Access to the webcast replay will be available approximately two hours after the completion of the call and will be archived on our website for approximately 90 days.
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NEXLIZET and NEXLETOL are shown:
- The bempedoic acid component of NEXLIZET and NEXLETOL has been shown to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to receive recommended statin therapy, including those not taking statins.
- established cardiovascular disease (CVD), or
- The risk of CVD events is high, but CVD is not established.
- As a diet aid:
- NEXLIZET, alone or in combination with other LDL-C-lowering therapies, lowers LDL-C in adults with primary hyperlipidemia, including HeFH.
- NEXLETOL lowers LDL-C in adults with primary hyperlipidemia, including HeFH, in combination with other LDL-C-lowering therapies or alone if combined LDL-C-lowering therapy is not possible .
Important safety information
NEXLIZET and NEXLETOL are contraindicated in patients with a history of hypersensitivity to bempedoic acid, ezetimibe, or any excipient. Serious hypersensitivity reactions, including anaphylaxis, angioedema, rash, and hives, have been reported.
Hyperuricemia: Bempedoic acid, an ingredient in Nexlisette and Nexletol, can increase blood uric acid levels and cause gout. Hyperuricemia occurs early in treatment, persists throughout treatment, and may return to baseline after treatment is discontinued. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia and initiate treatment with uric acid-lowering drugs if necessary.
tendon rupture: Bempedoic acid, an ingredient in NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon ruptures may occur more frequently in patients over 60 years of age, those taking corticosteroids or fluoroquinolone drugs, those with renal failure, and those with previous tendon disease. Discontinue use of NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapies for patients with a history of tendinopathy or tendon rupture.
In primary hyperlipidemia studies of bempedoic acid, a component of Nexlisette and Nexletol, the most common side effects in 2% or more of patients and more common than placebo were upper respiratory tract infections, muscle spasms, and hyperuricemia. symptoms, back pain, abdominal pain, or discomfort. Bronchitis, pain in the extremities, anemia, elevated liver enzymes.
Side effects that were reported in more than 2% of patients treated with ezetimibe (a component of NEXLIZET), and whose incidence was higher than with placebo in clinical trials, include upper respiratory tract infections, diarrhea, joint pain, sinusitis, extremity I was in pain, tired, and had the flu.
In the primary hyperlipidemia trial of NEXLIZET, the most commonly reported side effects observed with NEXLIZET (incidence ≥3%, greater than placebo) were not observed in clinical trials with bempedoic acid or ezetimibe, but He had a urinary tract infection, nasopharyngitis, and constipation.
The most common side effects in cardiovascular outcome studies of bempedoic acid, a component of Nexriset and Nexletol, were hyperuricemia, kidney damage, anemia, elevated liver enzymes, muscle spasms, and gout, with an incidence of 2% or more. , 0.5% higher than placebo. , cholelithiasis.
Discontinue use of Nexlisette or Nexletol if you become pregnant, unless the benefits of treatment outweigh the potential risks to the fetus. Breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL due to the potential for serious side effects in breastfed infants.
Pregnancy may be reported to Esperion Therapeutics, Inc.’s Adverse Event Reporting Line at 1-833-377-7633.
View complete prescribing information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
Esperion discovers, develops and commercializes innovative medicines that help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. Currently, the health needs of millions of people with high cholesterol are not being met. That’s why our team of passionate industry leaders breaks through the barriers that prevent patients from achieving their goals. Healthcare providers work to lower LDL cholesterol levels as low as possible as quickly as possible. We provide the next steps to get patients there. Because if you have high cholesterol levels, achieving your goals is not optional. It is our life’s work. For more information, please visit: Esperion.com and esperionscience.com Follow me on X twitter.com/Esperion Co., Ltd.
CLEAR Cardiovascular Outcomes Study
CLEAR Outcomes is part of NEXLETOL’s CLEAR clinical research program® (Bempedoic acid) tablets and Nexlysit® (bempedoic acid and ezetimibe) tablets. The CLEAR program provides important information regarding the safety and efficacy of bempedoic acid, a first-in-class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET, and its potential role in addressing additional important unmet medical needs. We aim to generate clinical evidence. More than 60,000 people will participate by the time the program is complete. The CLEAR program includes five label-validated Phase III studies and other important studies that have the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C. Phase IV studies are included.
Forward-looking statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the federal securities laws, including, but not limited to, our marketing strategies and commercialization plans, our current and planned operating expenses, and our future expectations. Includes descriptions of operations, products, and clinical development. , the design and planning of the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and prospects, including anticipated funding runway; Other statements that include the word “expect”. , “intend”, “may”, “plan”, “anticipate”, “project”, “propose”, “target”, “could”, “will” , “would”, “could”, “should”, “continue”, etc. Statements contained in this press release, express or implied, that are not statements of historical fact are deemed forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual performance to differ materially from expectations. This includes Esperion’s commercial product net sales, profitability, growth, clinical activity and results, supply chain, commercial development, and implementation plans, the results of litigation proceedings and settlements, and anticipated benefits to the Securities and Exchange Commission. including the risks detailed in Esperion’s filings. The forward-looking statements contained in this press release speak only as of the date of this press release, and Esperion does not warrant the forward-looking statements contained in this press release, except to the extent required by law. We disclaim any obligation or undertaking to update or amend.
Esperion contact information:
Investor:
alexis callahan
[email protected]
(406) 539-1762
media:
Tiffany Aldrich
[email protected]
(616) 443-8438
The video accompanying this announcement is available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/9dbd002a-dfe8-4760-a27e-6700d15825b8
