Esperion Therapeutics

First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

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水曜日, 5月 22, 2024
ATP, ACL, Risk, Molina Healthcare, Ageing, Agent handling, Adverse event, CVD, Esperion Therapeutics, Back pain, Angioedema, Cholesterol, Gout, Kidney, Constipation, Treatment, Civil service commission, European Commission, Fetus, Anaphylaxis, Hypersensitivity, Moyamoya disease, Bempedoic acid, Urinary tract infection, Anemia, Hypercholesterolemia, Upper respiratory tract infection, Safety, Ezetimibe, CLEAR, Incidence, Bronchitis, Excipient, Diet, Gallstone, Rash, Patient, Cardiovascular disease, Diarrhea, Abdominal pain, Uric acid, Spasm, University, University of Milan, Therapy, Arthralgia, Sinusitis, Pregnancy, European, Stroke, Health, Common, Death, FDC, Fatigue, Myocardial infarction, Tablet, Rupture, Pain, CHMP, Dietary supplement

ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.

Key Points: 
  • Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further.
  • Bempedoic acid provided additional cholesterol lowering of up to 28% on top of statin therapy, compared to placebo.
  • “Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for the Treatment for Hypercholesterolemia

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月曜日, 5月 20, 2024
LDL, Patient, ATP, Hypercholesterolemia, Esperion Therapeutics, Liver, Therapy, ESPR, Safety, Week, ANN, Adenosine triphosphate, Pharmaceutical industry

The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to patients in Japan.

Key Points: 
  • The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to patients in Japan.
  • Bempedoic acid is marketed for the treatment of hypercholesterolemia and cardiovascular risk reduction in several regions of the world, including the United States and Europe.
  • In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion and is currently developing it domestically.
  • Trial participants were administered either 180 mg of bempedoic acid or a placebo, orally, once a day, for 12 weeks to evaluate the efficacy and safety of bempedoic acid.

Contineum Therapeutics Announces Appointment of Troy Ignelzi to Board of Directors

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月曜日, 5月 20, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Health Technology, Bristol Myers Squibb, Patient, Neuroscience, Abivax, Ferris State University, Depression, Esperies, Therapy, Sale, Insys Therapeutics, Idiopathic pulmonary fibrosis, Audit committee, IPO, Esperion Therapeutics, DSM-IV codes, Juventas, Inflammation, Eli Lilly, AstraZeneca, Pharmaceutical industry

Mr. Ignelzi brings nearly two decades of financial leadership and industry experience to Contineum’s board.

Key Points: 
  • Mr. Ignelzi brings nearly two decades of financial leadership and industry experience to Contineum’s board.
  • “I am extremely pleased to welcome Troy to the Contineum board.
  • Currently, Mr. Ignelzi serves as the Chief Financial Officer at Rapport Therapeutics, Inc., a precision neuromedicines company, where he has served since November 2023.
  • “I am excited to bring my experience with neuroscience companies to the Contineum board and help guide the company’s financial strategy and growth.”

First-in-class cholesterol-lowering treatment NILEMDO®▼ and its combination with ezetimibe, NUSTENDI®▼, approved in Europe to lower LDL cholesterol and reduce cardiovascular risk

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水曜日, 5月 22, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Moyamoya disease, Bempedoic acid, Patient, Cardiovascular disease, ATP, ACL, Risk, Molina Healthcare, University, Hypercholesterolemia, University of Milan, Therapy, Ageing, European, Agent handling, Ezetimibe, Civil service commission, European Commission, Death, Esperion Therapeutics, FDC, Cholesterol, CHMP, Dietary supplement

With the new indication, which covers both primary and secondary prevention, we can support healthcare professionals to better meet the treatment needs in their daily practice.

Key Points: 
  • With the new indication, which covers both primary and secondary prevention, we can support healthcare professionals to better meet the treatment needs in their daily practice.
  • At the same time, we’re confident it will reassure patients that their medication truly addresses their CV risk.
  • This reaffirms our commitment to be a trusted ally in improving cardiovascular care throughout Europe,” said Oliver Appelhans, Head of Europe Specialty Division, Daiichi Sankyo Europe GmbH.
  • “We are delighted with the European Commission’s approval, 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.

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

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日曜日, 4月 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

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

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水曜日, 3月 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

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金曜日, 3月 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

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

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金曜日, 3月 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

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

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金曜日, 3月 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

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金曜日, 3月 22, 2024
FDA, Health, Other Health, Pharmaceutical, Cardiology, Biotechnology, Photograph, Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Webcast, Committee, Spasm, Splenic infarction, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, U.S. FDA, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Rupture, Molina Healthcare, Hypersensitivity, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Multimedia, Uric acid, Dietary supplement

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.