Tag: Nexletol

Esperion Announces Submission of Supplemental New Drug Applications to U.S. FDA for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet

– Submitted four efficacy supplements seeking inclusion of CV risk reduction and expansion of LDL-C lowering –  – Anticipated approvals in U.S. in the first half of 2024 –  ANN ARBOR, Mich., June 01, 2023 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced that it has submitted Supplemental New Drug Applications (sNDA) to […]

Landmark CLEAR Outcomes Study Demonstrates NEXLETOL® (bempedoic acid) Tablet is the Only LDL-C Lowering Therapy Since Statins to Reduce Hard Ischemic Events in a Broad Population of Both Primary Prevention and Secondary Prevention Patients

Results Demonstrate Significant Reductions in LDL-C, hsCRP and Cardiovascular Risk in Patients Who Are Unable to Maximize or Tolerate a Statin – NEXLETOL Significantly Reduced Risk of Major Adverse Cardiovascular Events (MACE-4) and (MACE-3) by 13% (P=0.004) and 15% (P=0.006), Respectively, and Significantly Reduced Risk of Myocardial Infarction by 23% (P=0.002) […]

Esperion Announces CLEAR Cardiovascular Outcomes Trial of NEXLETOL® (bempedoic acid) Meets Primary Endpoint

– Demonstrates statistically significant and clinically meaningful results – – Bempedoic acid becomes the first ATP citrate lyase inhibitor and first oral non-statin to meet the major adverse cardiovascular events (MACE-4) primary endpoint –                   – Presentation of comprehensive data at a key medical conference in the first quarter of 2023 – ANN ARBOR, […]

Esperion Announces Two NEXLETOL® (bempedoic acid) Data Presentations at the American College of Cardiology’s 71st Annual Scientific Session & Expo

New Analyses of thousands of patients spanning Phase 2 and pooled Phase 3 data demonstrate that NEXLETOL safely and significantly lowers LDL-C compared to placebo in patients with renal impairment or hypertension ANN ARBOR, Mich., April 03, 2022 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today presented two new analyses from […]

NEXLETOL® (bempedoic acid) Tablets Highlighted in EAS 2020 Presentation of Analysis Demonstrating Significant Cholesterol Lowering in People with Familial Hypercholesterolemia

– NEXLETOL® exhibited a 22% mean reduction in LDL-C levels in patients with Heterozygous Familial Hypercholesterolemia at week-12 – ANN ARBOR, Mich., Oct. 07, 2020 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced results of pooled data from two of the company’s Phase 3 trials were presented at the virtual […]