Nabil Abadir, CMO and Head of Global Medical Affairs at Amarin Corp Shares Insights from New Data Evaluating Vascepa/Vazkepa at ACC.23/WCC

Shots:

Nabil spoke about the data evaluating Vascepa/Vazkepa and eicosapentaenoic acid in reducing cardiovascular events presented at the ACC.23/WCC
He also told our readers about the new analysis from the REDUCE-IT trial showing the effectiveness of VASCEPA/VAZKEPA in patients with recent acute coronary syndrome
The interview shows how Amarin is developing innovative therapies, increasing the scientific understanding of cardiovascular risk, and advancing the treatment of that risk

Smriti: To begin with please tell us about your experience at joint ACC.23/WCC.

Nabil Abadir: As always, this year’s meeting was a terrific opportunity to listen live to some of the top scientists share the latest research and data, connect in person with colleagues, key opinion leaders and other stakeholders and discuss the latest science in cardiovascular medicine, including new data for VASCEPA/VAZKEPA and EPA.

Smriti: Highlight the data related to VASCEPA/VAZKEPA (icosapent ethyl) and eicosapentaenoic acid (EPA) presented at the congress.

Nabil Abadir: Notable VASCEPA data presented at the meeting included an exciting post-hoc analysis of the REDUCE-IT trial, which was featured in an oral session highlighting original research in ischemic heart disease. The new analysis reconfirmed yet again the value of VASCEPA and showed that VASCEPA substantially and significantly reduced the risk of first and total ischemic events by 37% and 36% respectively in patients with recent acute coronary syndrome or ACS, without increasing bleeding, supporting early initiation of VASCEPA after ACS.

Additionally, new in vitro data on the potential mechanistic effects of EPA in reducing cardiovascular events in at-risk patients were presented at the meeting. These in vitro analyses demonstrated that EPA is highly effective in improving endothelial function by reducing lipoprotein oxidation, a central driver of atherosclerosis, and would therefore be considered protective against heart disease. These mechanisms may help explain the significant risk reduction benefit demonstrated in the REDUCE-IT trial for VASCEPA. The research also underscores confidence in the results of REDUCE-IT with mineral oil as that placebo comparator, which did not have any biologically active effects on membrane oxidation.

Smriti: Shed some light on the study design of the REDUCE-IT clinical trial.

Nabil Abadir: The Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention or REDUCE-IT Trial was designed to emphasize the benefits of VASCEPA in reducing the risk of cardiovascular events when paired with a statin.

REDUCE-IT was a Phase 3b global, randomized, double-blinded, placebo-controlled trial of VASCEPA versus placebo. The cardiovascular outcomes study was designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled by statin therapy and various cardiovascular risk factors and persistent elevated triglycerides. The study also included patients who were living with either established cardiovascular disease or diabetes mellitus and at least one other cardiovascular risk factor.

Conducted over seven years and completed in 2018, REDUCE-IT followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. The primary results were published in The New England Journal of Medicine in November 2018, in which the gold standard cardiovascular clinical endpoints showed VASCEPA achieved an unprecedented 25% relative risk reduction to LDL-C and 20% lower risk of cardiovascular-related death.

Smriti: How can the combination of VASCEPA/VAZKEPA with statins help to reduce the risk of cardiovascular disease globally?

Nabil Abadir: The groundbreaking REDUCE-IT study demonstrated that VASCEPA, the only oral therapy approved by the U.S. FDA in combination with a statin to reduce cardiovascular risk in appropriate patients as studied in REDUCE-IT, lowers the chance of cardiovascular events, such as a heart attack or stroke, by 25%, and the risk of cardiovascular death by 20%.

REDUCE-IT data have led to multiple global regulatory approvals for cardiovascular risk reduction and adoption of VASCEPA on various global clinical practice guidelines and scientific/consensus statements for atherosclerotic cardiovascular disease risk reduction. Further, the trial data have demonstrated positive outcomes among multiple sub-populations including those with acute coronary syndrome, prior myocardial infarction, prior revascularization, prior peripheral arterial disease and diabetes.

Smriti: Please brief our readers about the VASCEPA/VAZKEPA capsules.

Nabil Abadir: VASCEPA capsules are a highly purified, prescription form of EPA, which is an omega-3 polyunsaturated fatty acid that is differentiated from omega-3 supplements that are available over the counter.

VASCEPA was the first and only medication approved by the U.S. FDA, in combination with statins to lower cardiovascular risk in patients with high triglycerides and established cardiovascular disease or diabetes with other cardiovascular risk factors.

While the mechanism of action of VASCEPA is not fully understood, icosapent ethyl is the only active ingredient in VASCEPA and is considered the reason behind the significant cardiovascular benefits VASCEPA can deliver.

VASCEPA, formulated as a capsule, has a concentration of 1 gram per capsule and is the only treatment in its class approved with a dose of 4 grams a day, which has been shown to provide clinical benefits and significant risk reduction in clinical trials.

From other multiple trials, it is clear that a low dosage of EPA and/or combining EPA with other omega-3 fatty acids, such as DHA, may lead to a lack of clinical effectiveness.

Beginning with the identification and development of what would become VASCEPA nearly 20 years ago, we are proud to be able to reduce the persistent cardiovascular risk that many patients face despite the use of statins with other contemporary standard-of-care therapies.

Smriti: Lastly, can you please give a glimpse of Amarin’s pipeline apart from VASCEPA/VAZKEPA.

Nabil Abadir: Through our research and development efforts, we are focused on improving cardiovascular health. Cardiovascular disease is the leading cause of death and we are committed to developing therapeutics to address the unmet needs of all cardiovascular patients.

Our product development program leverages our extensive experience in lipid science, and the potential therapeutic benefits of polyunsaturated fatty acids including a commitment to future product developments.

One key effort and focus currently is to advance our fixed-dose combination or FDC, which is centered on icosapent ethyl in combination with a statin. The combination therapy is in the early stages of development but if successful, would offer patients more convenience and hopefully drive an increase in compliance and adherence.

Image Source: Canva

About the Author: 

Nabil Abadir is the CMO and Head of Global Medical Affairs at Amarin Corp. Dr. Abadir joined Amarin in April 2022 as Chief Medical Officer and Head of Global Medical Affairs. Dr. Abadir is a medical doctor with more than 25 years of experience in the pharmaceutical and biotechnology industry. Throughout his career, he has successfully built and strengthened medical organizations at the local, regional, and global levels.