In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
'We are pleased to receive approval for our highly anticipated label expansions in the
'We are thrilled with these significantly expanded labels and look forward to being able to now reach millions more patients with our life-saving drugs. In anticipation of these approvals, we have significantly ramped up our sales force, developed a powerful suite of new promotional materials, created a bold new consumer campaign, enhanced our patient support programs, and continued working with payers to ensure improved patient access.'
'NEXLETOL and NEXLIZET are once-daily, accessible, oral medications that reduce LDL-C and cardiovascular risk, but without the side effects most common to statins. NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients. We believe this significantly differentiated profile is a game changer for patients and healthcare providers alike and that we expect sales to meaningfully inflect as a result. I want to thank the entire Esperion team for its unwavering commitment to patients and to getting us to this stage. I have the utmost confidence in our future success.'
The Company's pending label expansions in
The
27% for nonfatal myocardial infarction
19% for coronary revascularization
39% for MACE-3 in primary prevention patients
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol - that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life's work.
CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL (bempedoic acid) Tablet and NEXLIZET (bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to generate important clinical evidence on the safety and efficacy of bempedoic acid, a first in a class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential role in addressing additional critical unmet medical needs. More than 60,000 people will have participated in the program by the time of its completion. The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, and other statements containing the words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'predict,' 'project,' 'suggest,' 'target,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'continue,' and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion's filings with the
Contact:
Email: investorrelations@esperion.com
Tel: (406) 539-1762
Email: corporateteam@esperion.com
Tel: (616) 443-8438
(C) 2024 Electronic News Publishing, source