This section highlights FDA-related milestones and regulatory updates for drugs developed by Amarin (AMRN).
Over the past two years, Amarin has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VASCEPA/VAZKEPA and VAZKEPA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VASCEPA/VAZKEPA (icosapent ethyl) - FDA Regulatory Timeline and Events
VASCEPA/VAZKEPA (icosapent ethyl) is a drug developed by Amarin for the following indication: Prior Peripheral Artery Disease (PAD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VASCEPA/VAZKEPA (icosapent ethyl)
- Announced Date:
- February 27, 2025
- Indication:
- Prior Peripheral Artery Disease (PAD)
Announcement
Amarin Corporation plc today highlighted recently published data in the Journal of the American Heart Association (JAHA) showing in a post-hoc analysis of the landmark REDUCE-IT study that, among statin-treated patients with elevated triglycerides and high cardiovascular risk, VASCEPA®/VAZKEPA® (icosapent ethyl) (IPE) reduced composite cardiovascular (CV) endpoint events regardless of baseline levels of low-density lipoprotein cholesterol (LDL-C <55mg/dL or ≥55mg/dL).
AI Summary
Amarin Corporation plc has highlighted new findings from the Journal of the American Heart Association based on a post-hoc analysis of the landmark REDUCE-IT study. The analysis showed that for statin-treated patients with high cardiovascular risk and elevated triglycerides, treatment with VASCEPA®/VAZKEPA® (icosapent ethyl, IPE) significantly reduced composite cardiovascular events regardless of baseline low-density lipoprotein cholesterol (LDL-C) levels. Specifically, even patients with very well-controlled LDL-C (<55 mg/dL) experienced a 34% reduction in cardiovascular events, while those with LDL-C levels ≥55 mg/dL also benefited from the treatment.
These results underline the role of IPE as an effective complementary therapy to LDL-C lowering treatments. The findings suggest that adding IPE to standard treatment regimens can further reduce cardiovascular risk and potentially improve patient outcomes in high-risk populations.
Read Announcement- Drug:
- VASCEPA/VAZKEPA (icosapent ethyl)
- Announced Date:
- September 9, 2024
- Indication:
- Prior Peripheral Artery Disease (PAD)
Announcement
Amarin Corporation plc announced that new supported and/or funded research on the clinical impact of VASCEPA®/VAZKEPA (icosapent ethyl) in patients with diabetes and high cardiovascular risk and the anti-Lp(a) oxidation mechanistic effects of eicosapentaenoic acid (EPA) will be presented at the 60th Annual European Association for the Study of Diabetes (EASD) Meeting September 9 – 13, 2024 in Madrid, Spain.
AI Summary
Amarin Corporation plc announced that it will present new supported and funded research at the 60th Annual European Association for the Study of Diabetes (EASD) Meeting in Madrid, Spain, from September 9 to 13, 2024. The highlighted studies will focus on two key areas: the clinical impact of VASCEPA/VAZKEPA (icosapent ethyl) in patients with diabetes and high cardiovascular risk, and the anti-Lp(a) oxidation mechanistic effects of eicosapentaenoic acid (EPA). The clinical research aims to further understand how VASCEPA/VAZKEPA can help reduce residual cardiovascular risk in diabetic patients, while the mechanistic study will explore how EPA prevents the oxidation of Lp(a), a process associated with cardiovascular complications. These initiatives demonstrate Amarin’s commitment to advancing scientific knowledge and improving treatment options for patients facing serious cardiovascular challenges.
Read Announcement- Drug:
- VASCEPA/VAZKEPA (icosapent ethyl)
- Announced Date:
- August 22, 2024
- Indication:
- Prior Peripheral Artery Disease (PAD)
Announcement
Amarin Corporation plc announced new supported and/or funded subgroup data from the landmark REDUCE-IT® cardiovascular outcomes trial with VASCEPA®/VAZKEPA® (icosapent ethyl), as well as abstracts showcasing the mechanistic activity of eicosapentaenoic acid (EPA) that will be presented at the European Society of Cardiology (ESC) Congress in London, United Kingdom, August 30 – September 2, 2024.
AI Summary
Amarin Corporation plc today announced that it will showcase new subgroup data from its landmark REDUCE‑IT cardiovascular outcomes trial with VASCEPA®/VAZKEPA® (icosapent ethyl). The company also revealed that several abstracts focusing on the mechanistic activity of eicosapentaenoic acid (EPA) will be presented at the European Society of Cardiology (ESC) Congress in London from August 30 to September 2, 2024.
The presentations include analyses examining whether baseline small dense LDL cholesterol alters the effect of icosapent ethyl on cardiovascular events, as well as studies on the link between triglycerides and cardiovascular risk in patients with acute coronary syndrome. Other abstracts will estimate the number of eligible ACS patients for treatment in Spanish hospitals and show how EPA limits oxidation of Lp(a) under high glucose conditions. These supported studies underscore Amarin’s commitment to reducing residual cardiovascular risk beyond traditional lipid management.
Read Announcement- Drug:
- VASCEPA/VAZKEPA (icosapent ethyl)
- Announced Date:
- July 8, 2024
- Indication:
- Prior Peripheral Artery Disease (PAD)
Announcement
Amarin Corporation plc announced that its commercial partner in Mainland China ("China"), EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China's National Medical Products Administration (NMPA).
AI Summary
Amarin Corporation announced that its Mainland China partner, EddingPharm, has received regulatory approval from China's National Medical Products Administration for VASCEPA® (icosapent ethyl). This approval allows VASCEPA to be used with statin therapy to reduce the risk of cardiovascular events in adult patients with elevated triglyceride levels and additional high-risk factors such as established cardiovascular disease or diabetes accompanied by at least two other risk factors.
With the NMPA’s clearance, EddingPharm is now working to include VASCEPA on the National Reimbursement Drug Listing (NRDL), which is crucial for public reimbursement and broader access in China. This milestone marks an important step in making VASCEPA available to a larger number of patients who could benefit from this innovative treatment for cardiovascular risk reduction.
Read Announcement- Drug:
- VASCEPA/VAZKEPA (icosapent ethyl)
- Announced Date:
- April 6, 2024
- Indication:
- Prior Peripheral Artery Disease (PAD)
Announcement
Amarin Corporation plc 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.
AI Summary
Amarin Corporation, in partnership with HLS Therapeutics Inc., recently presented new data at ACC.24 showing that VASCEPA® (icosapent ethyl) effectively reduces major adverse cardiovascular events (MACE). The REDUCE-IT trial analyses revealed that the benefits of VASCEPA were consistent in patients regardless of their baseline Lipoprotein(a) levels—whether high or low. Additionally, the data showed that VASCEPA reduced the risk of cardiovascular events in patients irrespective of their baseline LDL-C levels, including those with LDL-C levels below or above 55 mg/dL. These findings provide further insight into how VASCEPA can help manage cardiovascular risk when added to standard care, reinforcing its clinical benefit among at-risk patients. The study results have been jointly published in the Journal of the American College of Cardiology (JACC).
Read Announcement
VAZKEPA - FDA Regulatory Timeline and Events
VAZKEPA is a drug developed by Amarin for the following indication: For Cardiovascular Risk.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VAZKEPA
- Announced Date:
- June 24, 2025
- Indication:
- For Cardiovascular Risk
Announcement
Amarin Corporation announced that the Company has entered into an exclusive long-term license and supply agreement (the "Agreement") with Recordati S.p.A. ("Recordati") to commercialize VAZKEPA® (icosapent ethyl) across 59 countries, focused in Europe.
AI Summary
Amarin Corporation has secured an exclusive, long-term license and supply agreement with Recordati S.p.A. to commercialize VAZKEPA® (icosapent ethyl) in 59 countries, primarily in Europe. Under this agreement, Recordati will take the lead on marketing and sales in the European region, leveraging its established infrastructure in cardiovascular care. Amarin will receive an immediate $25 million payment and has the potential to earn up to $150 million in milestone payments based on Recordati achieving certain annual commercial net sales. Additionally, Amarin will benefit from ongoing supply-based revenue, including royalties. This strategic partnership aims to increase patient access to VAZKEPA, known for its cardiovascular benefits when used in conjunction with statin therapy, and supports Amarin’s efforts to streamline its global operations and strengthen its financial position.
Read Announcement - Drug:
- VAZKEPA
- Announced Date:
- February 25, 2025
- Indication:
- For Cardiovascular Risk
Announcement
Amarin Corporation plc announced that Austria's Health Authorities have approved VAZKEPA® for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients with elevated triglycerides and established cardiovascular disease (eCVD). As of April 1st 2025, VAZKEPA® will be included in Austria's Code of Reimbursement (EKO).
AI Summary
Amarin Corporation plc announced that Austria’s Health Authorities have approved VAZKEPA® for national reimbursement, effective April 1, 2025. This approval means that VAZKEPA®, a treatment designed to reduce the risk of cardiovascular events, will now be part of Austria’s Code of Reimbursement (EKO). The medication is targeted at adult patients who are already on statin therapy but still have elevated triglyceride levels along with established cardiovascular disease (eCVD).
This decision highlights Austria’s commitment to tackling cardiovascular health challenges by giving doctors a new treatment option for patients who remain at risk despite existing therapies. The inclusion of VAZKEPA® in the reimbursement system is expected to ease the burden on healthcare services and provide a promising therapeutic alternative for patients in secondary prevention of cardiovascular disease.
Read Announcement- Drug:
- VAZKEPA
- Announced Date:
- December 16, 2024
- Indication:
- For Cardiovascular Risk
Announcement
Amarin Corporation plc announced that Italy's National Health Service (NHS) approved VAZKEPA® for national reimbursement to reduce cardiovascular risk in eligible high-risk patients, as published in the Official Journal of the Italian Republic (i.e. Gazzetta Ufficiale della Repubblica Italiana)1.
AI Summary
Amarin Corporation plc announced that Italy’s National Health Service (NHS) has approved VAZKEPA® for national reimbursement to help reduce cardiovascular risk in eligible high-risk patients. This approval, published in the Official Journal of the Italian Republic, targets patients with established cardiovascular disease who are at risk of recurrent events, such as myocardial infarction and stroke, even when their LDL-C levels are well managed. The decision highlights Italy’s approach to addressing the burden of cardiovascular disease, which is a leading cause of death and hospitalizations. By granting reimbursement for VAZKEPA®, Italian health authorities provide clinicians with an additional treatment option aimed at reducing the likelihood of further cardiovascular events in high-risk groups, reinforcing the potential of icosapent ethyl as an effective therapy for improving patient outcomes in Italy.
Read Announcement
