Esperion Therapeutics

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sunday, April 7, 2024
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ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

One Biosciences Welcomes Dr. Scott Braunstein and Dr. Vincent Miller to its Board of Directors

Retrieved on: 
Wednesday, March 27, 2024
Constellation, Single-cell analysis, Lung cancer, EGFR, Health, Biotechnology, Rachel Haurwitz, New Jersey Medical School, Foundation Medicine, Cornell University, University, Knowledge, American Cancer Society, Research, Esperion Therapeutics, Cancer, A.I, Medicine, Summit Health, Esperies, Therapy, Drug development, Partner, MorphoSys, JPMorgan Chase, Thomas Jefferson University Hospital

to identify a new generation of precision medicine targets and develop new treatments, today announced the appointments of Dr. Scott Braunstein, and Dr. Vincent Miller, to its Board of Directors.

Key Points: 
  • to identify a new generation of precision medicine targets and develop new treatments, today announced the appointments of Dr. Scott Braunstein, and Dr. Vincent Miller, to its Board of Directors.
  • Our proprietary discovery engine has identified its first promising targets, and we are preparing to start drug development activities in 2025.
  • Bolstering our Board with such seasoned leaders will be a key factor to success.”
    Dr. Scott Braunstein brings over 30 years of knowledge and experience gained in the biotechnology, pharmaceutical, and biotech portfolio management industries.
  • Dr. Braunstein is currently on the board at Trevena and Caribou Biosciences.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
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In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • 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.
  • 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.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
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ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed-dose combination tablet as treatments for hypercholesterolaemia and significantly reducing cardiovascular events

Retrieved on: 
Friday, March 22, 2024
Health, Biometrics, General Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Hypercholesterolemia, European Commission, Bempedoic acid, Risk, Patient, Tablet, Committee, ACL, Ageing, Agent handling, Esperion Therapeutics, EMA, Death, European Medicines Agency, Ezetimibe, Therapy, Moyamoya disease, ATP, FDC, CHMP, Apolipoprotein, Pharmaceutical industry

“The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.

Key Points: 
  • “The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.
  • This first-in-class medicine with proven efficacy in reducing hypercholesterolaemia and preventing cardiovascular risks, is a testament to our tireless efforts to help improve the cardiovascular treatment landscape.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
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In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • 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.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Sofinnova Investments Appoints Troy Ignelzi as Executive Advisor

Retrieved on: 
Tuesday, March 12, 2024
Professional Services, Health, Other Science, Finance, Research, Science, Biotechnology, RAPS, Eli Lilly, AstraZeneca, Ferris State University, Patient, Esperion Therapeutics, Sale, IPO, Pleasure, Esperies, Insys Therapeutics, Therapy, Investment, Multimedia, Pharmaceutical industry

Sofinnova Investments , a healthcare investment firm, announced today the appointment of Troy Ignelzi to the investment team as an Executive Advisor.

Key Points: 
  • Sofinnova Investments , a healthcare investment firm, announced today the appointment of Troy Ignelzi to the investment team as an Executive Advisor.
  • View the full release here: https://www.businesswire.com/news/home/20240312683597/en/
    Mr. Ignelzi brings to Sofinnova over two decades of financial leadership experience in the biotech and pharmaceuticals sectors.
  • Over the course of his career, Mr. Ignelzi has raised an impressive $4 billion-plus in capital for life science companies.
  • We are extremely pleased to have him join us,” said Jim Healy, M.D., Ph.D., Managing Partner, Sofinnova Investments.

RFK, Esperion Therapeutics Announce 2024 Promotional Schedule

Retrieved on: 
Thursday, February 1, 2024
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CONCORD, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- RFK Racing and Esperion Therapeutics have announced the promotional schedule for the 2024 season, highlighted by a four-race slate, and numerous accompanying campaigns and initiatives, all driving awareness of its two brands – NEXLIZET (bempedoic acid and ezetimibe) and NEXLETOL (bempedoic acid) used for adults on a statin to reduce LDL-cholesterol.

Key Points: 
  • CONCORD, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- RFK Racing and Esperion Therapeutics have announced the promotional schedule for the 2024 season, highlighted by a four-race slate, and numerous accompanying campaigns and initiatives, all driving awareness of its two brands – NEXLIZET (bempedoic acid and ezetimibe) and NEXLETOL (bempedoic acid) used for adults on a statin to reduce LDL-cholesterol.
  • Brad Keselowski’s debut with the brand comes at the All-Star Race at North Wilkesboro (May 19).
  • In addition, Buescher will attend the annual American College of Cardiology (ACC) session on behalf of Esperion, in April in Atlanta.
  • “Our partnership thus far with RFK has proven to be very successful in many facets, and we’re excited to again embark on a new journey with the team in 2024,” said Sheldon Koenig, CEO, Esperion.

Care Access Becomes Newest Member of the National Lipid Association Industry Council, Joining Novartis, Amgen, and Other Cardiovascular Health Leaders

Retrieved on: 
Wednesday, January 31, 2024
Research, Surgery, Clinical Trials, Cardiology, Practice Management, Other Health, Health, General Health, Science, Principal, Stenosis, Physician, Novartis, National Lipid Association, Regeneron Pharmaceuticals, Clinical trial, Access, Cardiovascular disease, Patient, Esperion Therapeutics, Entrepreneurship, Therapy, Risk, NLA, Coronary artery disease, Learning, Stroke, Medicine, Amgen, Esperies, JD, Pharmaceutical industry

Care Access, a global clinical research company helping to accelerate the future of medicine, is joining the National Lipid Association (NLA) Industry Council.

Key Points: 
  • Care Access, a global clinical research company helping to accelerate the future of medicine, is joining the National Lipid Association (NLA) Industry Council.
  • The collaboration aims to enable more community-based lipidologists to participate in clinical research and create access to cardiometabolic trials for their patients.
  • The NLA represents doctors and other experts from around the country who treat patients at the highest risks of cardiovascular disease.
  • "At Care Access, we are committed to facilitating clinical trial access for patients from all walks of life," said Ahmad Namvargolian, Care Access CEO and Co-Founder.

Esperion and Daiichi Sankyo Europe Announce $125 Million Amendment to Their Collaboration, Including Resolution of Pending Litigation

Retrieved on: 
Wednesday, January 3, 2024
Science, Cardiology, Other Science, Research, Pharmaceutical, Oncology, General Health, Health, Partnership, Tablet, Disability, EMA, ESPR, Esperion Therapeutics, Bempedoic acid, Therapy, Death, Calendar, European Medicines Agency, Patient, Cardiovascular disease, Ezetimibe, District court, Pharmaceutical industry

DSE will make an additional $25 million payment to Esperion in the calendar quarter immediately following EMA's decision on the pending application.

Key Points: 
  • DSE will make an additional $25 million payment to Esperion in the calendar quarter immediately following EMA's decision on the pending application.
  • The legal action pending in the United States District Court for the Southern District of New York will be dismissed.
  • Since 2019, Esperion and DSE have worked together to bring bempedoic acid to the eligible patient population and unlock its potential for cardiovascular risk reduction.
  • The partnership continues to grow, with DSE recently gaining approvals for bempedoic acid in the Netherlands, Slovakia, and Spain.