Ezetimibe

LIB Therapeutics Announces Positive Lerodalcibep Results from Two Phase 3 LIBerate Studies at the 92nd European Atherosclerosis Society Congress

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Mittwoch, Mai 29, 2024
Other Health, Research, Managed Care, Pharmaceutical, Clinical Trials, Science, Cardiology, Biotechnology, FDA, Other Science, Health, Diabetes, Patient, Cardiovascular disease, Doctor of Philosophy, EAS, Safety, PCSK9, Ezetimibe, MD, Week, CVD, Apolipoprotein, Concentration ratio, History, Liberation, Female, Pharmaceutical industry

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, once-monthly, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced positive results from two studies in the recently completed Phase 3 LIBerate registration-enabling program were presented during the 92nd European Atherosclerosis Society Congress in Lyon, France, May 26-29, 2024.

Key Points: 
  • LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, once-monthly, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced positive results from two studies in the recently completed Phase 3 LIBerate registration-enabling program were presented during the 92nd European Atherosclerosis Society Congress in Lyon, France, May 26-29, 2024.
  • The co-primary efficacy endpoints were the percent change from baseline in LDL-C at Week 52 and the mean of Weeks 50 and 52.
  • Secondary outcomes included achievement of EAS / ESC LDL-C targets, and other lipid and apolipoproteins changes.
  • Patients were randomized 2:1 to a single 300 mg once-monthly, subcutaneous dose of Lerodalcibep or placebo for 52 weeks.

New subgroup analyses of CLEAR Outcomes data showed bempedoic acid reduced the risk of major adverse cardiovascular events across various patient groups

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Mittwoch, Mai 29, 2024
Biometrics, Health, Pharmaceutical, Clinical Trials, Cardiology, Bempedoic acid, Patient, Cardiovascular disease, ATP, ACL, EAS, Risk, ACC, Obesity, Apolipoprotein, University, Diabetes, Metabolic syndrome, Preventive healthcare, Male, Safety, Agent handling, Metabolism, Ezetimibe, Congress, Death, CLEAR, Observational study, Incidence, Woman, Daiichi Sankyo, Human, Hyperuricemia, Metadata, Female, Pharmaceutical industry

Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced additional results from prespecified subgroup analyses of the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial.

Key Points: 
  • Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced additional results from prespecified subgroup analyses of the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial.
  • In the CLEAR Outcomes subgroup analysis of patients with or without MetS, treatment with bempedoic acid reduced the risk of MACE-4 to a similar extent.
  • “As clinicians, our priority is to reduce LDL-C levels to lower the risk of CV events.
  • Combination therapy with bempedoic acid may be one way to address this issue.”
    “Our goal at Daiichi Sankyo is to help protect people from cardiovascular disease.

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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Mittwoch, Mai 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.

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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Mittwoch, Mai 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.

Merck Announces First-Quarter 2024 Financial Results

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Donnerstag, April 25, 2024
Infectious Diseases, FDA, Diabetes, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Oncology, Acquisition, Research, Drug development, Ezetimibe, Investment, GAAP, EPS, Pharmaceutical industry

Research and development (R&D) expenses were $4.0 billion in the first quarter of 2024 compared with $4.3 billion in the first quarter of 2023.

Key Points: 
  • Research and development (R&D) expenses were $4.0 billion in the first quarter of 2024 compared with $4.3 billion in the first quarter of 2023.
  • GAAP EPS was $1.87 for the first quarter of 2024 compared with $1.11 for the first quarter of 2023.
  • Non-GAAP gross margin was 81.2% for the first quarter of 2024 compared with 76.9% for the first quarter of 2023.
  • Non-GAAP EPS was $2.07 for the first quarter of 2024 compared with $1.40 for the first quarter of 2023.

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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Sonntag, April 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.

Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session & Industry Expert Theatre to be Presented at ACC.24

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Montag, März 25, 2024
Health, Tablet, CVD, Bempedoic acid, Risk, Patient, CLEAR, Esperies, Ezetimibe, Safety, ATP, Pharmaceutical industry

At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Key Points: 
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • 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.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

NewAmsterdam Pharma to Present New Analysis from the Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe at 2024 American College of Cardiology Congress

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Montag, März 25, 2024
Moyamoya disease, Cardiovascular disease, Congress, Risk, Patient, NAMS, American College, Ezetimibe, Clinical trial, FDC, ACC, ASCVD

ROSE2 evaluated obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy; full results from the trial were previously presented at the National Lipid Association Scientific Sessions in June 2023.

Key Points: 
  • ROSE2 evaluated obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy; full results from the trial were previously presented at the National Lipid Association Scientific Sessions in June 2023.
  • At ACC, NewAmsterdam will share new data demonstrating obicetrapib and ezetimibe’s impact on small dense LDL-C, a robust predictor of residual risk of future cardiovascular events.
  • NewAmsterdam recently initiated TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC (‘fixed-dose combination”) in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.
  • Details of the presentation are as follows:
    Presentation at the 2024 American College of Cardiology (ACC) Congress:

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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Freitag, März 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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Freitag, März 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.