VASCEPA®/VAZKEPA® (ICOSAPENT ETHYL) CAPSULES


Associated tags: Eicosapentaenoic acid, Capsule, Patient, Diet, European, FDA, Hypertriglyceridemia, IPE, Food, Professional corporation, Pharmaceutical industry, Research

Locations: EUROPEAN UNION, CANADA, SWEDEN, LEBANON, ENGLAND, UNITED STATES, WALES, EUROPE, FINLAND, UNITED ARAB EMIRATES, DENMARK, CHINA, AUSTRIA, UK, SCOTLAND, SPAIN, NETHERLANDS

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

Retrieved on: 
Monday, April 8, 2024

These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.

Key Points: 
  • These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.
  • The beneficial effects of a high intensity statin and EPA on endothelial dysfunction may contribute to reduced atherothrombotic risk in outcome trials.
  • Elevated Lp(a) levels are an independent and causal risk factor for cardiovascular (CV) disease with limited treatments available.
  • The potent antioxidant actions of EPA may contribute to reduced CV events in REDUCE-IT, including among those subjects with elevated Lp(a).

New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

Retrieved on: 
Saturday, April 6, 2024

DUBLIN, Ireland and BRIDGEWATER, N.J., April 06, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted two data presentations at ACC.24 describing the effects of VASCEPA®/VAZKEPA® (icosapent ethyl) on reducing MACE (Major Adverse Cardiovascular Events) in patients with baseline high or low Lipoprotein(a) [Lp(a)] levels, as well as reducing the risk of cardiovascular (CV) events in patients irrespective of baseline LDL-C level. The REDUCE-IT analysis results relating Lp(a) concentrations with CV risk were also published online today in the Journal of the American College of Cardiology (JACC).

Key Points: 
  • There are no treatments currently approved to reduce residual CV risk on top of contemporary medical therapy in patients with high Lp(a) levels.
  • In this subanalysis, there were 7,026 REDUCE-IT patients with baseline Lp(a) data and a median Lp(a) value of 11.6 (Q1-Q3: 5.0-37.4) mg/dL.
  • Importantly, the treatment benefit of IPE was evident across subgroups with both high (≥50 mg/dL) and low (
  • Limitations are that randomization was not stratified by baseline LDL-C, however, baseline characteristics were similar among the two baseline LDL-C subgroups.

Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo

Retrieved on: 
Monday, March 25, 2024

DUBLIN, Ireland and BRIDGEWATER, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that additional patient subgroup analyses from the landmark REDUCE-IT outcomes trial and mechanistic data on icosapent ethyl (IPE)/eicosapentaenoic acid (EPA) will be presented at the American College of Cardiology’s Annual Scientific Session & Expo, April 6 – 8, 2024 in Atlanta, GA.

Key Points: 
  • These data demonstrate the molecule’s impact in reducing patients’ residual cardiovascular event risk across these patient sub-groups regardless of their baseline Lp(a) or LDL-C levels.
  • Additionally, the meeting provides an opportunity to highlight further evidence regarding the potential mechanistic activity of EPA in reducing cardiovascular events in at-risk patients."
  • “This latest research reaffirms Amarin's commitment to advancing cardiovascular care and should help further advance the medical community’s understanding of the role, the value and the potential mechanism of action of VASCEPA/VAZKEPA to reduce cardiovascular events in at-risk patients globally,” concluded Abadir.
  • Featured Amarin-supported abstracts to be presented by international academic collaborators at ACC Scientific Sessions 2024 include:

Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024

DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced financial results for the quarter and year ended December 31, 2023 and provided an update on the Company’s operations.

Key Points: 
  • Net product revenue for the three months ended December 31, 2023 was $70.6 million, compared to $89.5 million in the corresponding period of 2022, a decrease of 21%.
  • USA net product revenue was $64.9 million for the three months ended December 31, 2023 compared to $88.0 million in the corresponding period of 2022.
  • Cost of goods sold for the three months ended December 31, 2023 was $29.6 million, compared to $26.6 million in the corresponding period of 2022.
  • As of December 31, 2023, Amarin reported aggregate cash and investments of $321 million.

Amarin Provides Preliminary Fourth Quarter 2023 Selected Financials and Outlines Key Priorities For 2024

Retrieved on: 
Wednesday, January 10, 2024

-- Amarin to Present at 42nd Annual J.P. Morgan Healthcare Conference on January 10, 2024 --

Key Points: 
  • Cash Position: Amarin ended 2023 with approximately $321 million in cash and investments, with positive cash flow of approximately $10 million for the full year.
  • “In 2023, our team focused and delivered on our priorities that advanced our strategy,” said Patrick Holt, President & CEO of Amarin.
  • Amarin delivered approximately 65% growth in the fourth quarter versus the third quarter 2023.
  • Amarin anticipates that these steps could be completed by the end of the second quarter of 2024, with share repurchases commencing shortly thereafter.

New REDUCE-IT® Analyses Show VASCEPA® (icosapent ethyl) Associated with 29 Percent Relative Risk Reduction Compared with Placebo in Prespecified Subgroup of Patients with Metabolic Syndrome, but Without Diabetes at Baseline

Retrieved on: 
Sunday, November 12, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 12, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced results from new REDUCE-IT analyses showing that among statin-treated patients in a prespecified subgroup with history of Metabolic Syndrome, but without diabetes at baseline, the addition of VASCEPA/VAZKEPA (icosapent ethyl) significantly reduced the risk of first and total cardiovascular events. This subgroup was almost exclusively comprised of patients with established cardiovascular disease. The results were presented today at the American Heart Association (AHA) Scientific Sessions 2023, taking place November 11 – 13, 2023 in Philadelphia, PA and simultaneously published in the European Heart Journal Open.

Key Points: 
  • This subgroup was almost exclusively comprised of patients with established cardiovascular disease.
  • The results were presented today at the American Heart Association (AHA) Scientific Sessions 2023, taking place November 11 – 13, 2023 in Philadelphia, PA and simultaneously published in the European Heart Journal Open.
  • The large relative and absolute risk reductions observed supports IPE as an important therapeutic option for patients with metabolic syndrome at high cardiovascular risk, despite lacking robust effects on any metabolic syndrome component.
  • In addition, variation in subjective measures (e.g., waist circumference) may have affected classification of metabolic syndrome.

Amarin Partner EddingPharm Receives Regulatory Approval for Vascepa® (Icosapent Ethyl) in Mainland China

Retrieved on: 
Thursday, June 1, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in China, EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL).

Key Points: 
  • DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in China, EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA).
  • NMPA granted approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL).
  • Following regulatory approval, EDDING is now focusing on National Reimbursement Drug Listing (NRDL) and preparing for commercial launch in China, expected by year-end, as well as on advancing regulatory submission and review for an additional indication in cardiovascular risk reduction (CVRR).
  • Following the NMPA approval for this indication, Amarin is now entitled to receive a regulatory milestone payment of $5 million.

Amarin Highlights New Data Providing Potential Mechanistic Insight into Vascepa®/Vazkepa® (Icosapent Ethyl) Reduction of Cardiovascular Events

Retrieved on: 
Friday, May 12, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., May 12, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted new data describing the benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) on coronary physiology, which was published in the European Heart Journal - Cardiovascular Imaging, and plaque progression, which was presented at the American Heart Association’s Vascular Discovery 2023 meeting in Boston, MA, May 10-13.

Key Points: 
  • EVAPORATE demonstrated that in statin-treated patients, VASCEPA/VAZKEPA significantly reduced plaque burden measured by serial coronary computed tomography angiography (CTA) compared with placebo.
  • VASCEPA/VAZKEPA improved mean distal segment FFRCT at 9- and 18-months follow-up compared with placebo (P = 0.02, P = 0.03 respectively).
  • “These new findings from two different studies provide important mechanistic information about VASCEPA/VAZKEPA and further elucidate its value in reducing cardiovascular events in at-risk patients,” said Nabil Abadir, MB.
  • We are proud to add to the body of research that further demonstrates the benefit of VASCEPA/VAZKEPA."

Amarin Highlights New Evidence of Therapeutic Value of EPA in Reducing Cardiovascular Events in At-Risk Patients Presented at ACC.23/WCC

Retrieved on: 
Monday, March 6, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., March 06, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted new in vitro data supporting the potential mechanistic effects of eicosapentaenoic acid (EPA) in reducing cardiovascular events in at-risk patients presented at the joint ACC.23 together with the World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA, March 4-6, 2023.

Key Points: 
  • “The findings shared at ACC.23/WCC provide additional insight into the unique role of EPA in reducing cardiovascular events in at-risk patients around the world.
  • These mechanisms may help explain the significant risk reduction benefit demonstrated in the REDUCE-IT trial for icosapent ethyl.
  • By contrast, EPA significantly inhibited sdLDL and VLDL oxidation by 75% and 94%, respectively, compared with vehicle (p
  • While DHA exhibited antioxidant activity at 2 hours at a level less than EPA, this effect was eliminated by 4 hours.

Amarin Corporation to Present New Data Evaluating VASCEPA®/VAZKEPA® (Icosapent Ethyl) at ACC.23/WCC

Retrieved on: 
Monday, February 27, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data evaluating the role of VASCEPA®/VAZKEPA® (icosapent ethyl) and eicosapentaenoic acid (EPA) in reducing cardiovascular events in at-risk patients will be presented at the joint ACC.23 together with the World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA, March 4-6, 2023.

Key Points: 
  • DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data evaluating the role of VASCEPA®/VAZKEPA® (icosapent ethyl) and eicosapentaenoic acid (EPA) in reducing cardiovascular events in at-risk patients will be presented at the joint ACC.23 together with the World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA, March 4-6, 2023.
  • The featured research includes an analysis from the landmark REDUCE-IT trial on the effects of VASCEPA/VAZKEPA (icosapent ethyl) in patients with recent acute coronary syndrome (
  • “We are delighted to share new findings from the REDUCE-IT trial and add to the wealth of data that has consistently validated the utility of icosapent ethyl in treating patient sub-populations at high risk for cardiovascular disease,” said Nabil Abadir, MB.
  • CH.B., Chief Medical Officer and Head of Global Medical Affairs, Amarin.