INTENDED FOR UNITED KINGDOM MEDIA
The Medicines and Healthcare products Regulatory Agency (MHRA) gives green light to a proven new treatment to reduce the risk of cardiovascular events 1,2
Vazkepa® (icosapent ethyl) is the first and only authorised treatment in Great Britain and Europe to reduce cardiovascular risk in statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other high-risk characteristics as studied in REDUCE-IT.1,2,3
DUBLIN, Ireland, Apr. 22nd, 2021 – Amarin Corporation plc (Amarin) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Great Britain Marketing Authorisation* for Vazkepa® (icosapent ethyl) as a treatment to reduce the risk of cardiovascular events in high cardiovascular risk statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes, and at least one additional cardiovascular risk factor. For study details including cardiovascular risk factors and results with respect to effects on cardiovascular events see section 5.1 of the Vazkepa Summary of Product Characteristics.1
The MHRA’s license swiftly follows the European Commission marketing authorisation for icosapent ethyl on 30 March 2021.3 Amarin’s understanding is that icosapent ethyl is amongst the first products to be submitted and licensed through the MHRA’s new ‘reliance’ route following the end of the BREXIT transition period. Icosapent ethyl has been identified as a new active substance3 with likely multi-factorial mechanisms of action.1 The mechanisms of action contributing to reduction of cardiovascular events with icosapent ethyl are not completely understood.1
Marketing authorisation of icosapent ethyl comes after a decade of designing and conducting evidence-based cardiovascular clinical outcomes research. In the landmark international, double-blind randomised, placebo-controlled, event-driven REDUCE-IT study in 8,179 statin-treated adult patients with moderately elevated triglyceride levels, were followed for a median duration of 4.9 years.2
Icosapent ethyl achieved the primary composite endpoint (time to first occurrence of cardiovascular death, heart attack, stroke, coronary revascularisation or hospitalisation for unstable angina) with a 25% relative risk reduction and a 4.8% absolute risk reduction in the first occurrence of major adverse cardiovascular events in comparison to placebo.2 Icosapent ethyl also demonstrated a 26% relative risk reduction and a 3.6% absolute risk reduction in the key secondary composite endpoint (time to first occurrence of cardiovascular death, heart attack or stroke).2 For further information on the key clinical effects of icosapent ethyl in REDUCE-IT see Table 1.
The most frequently reported adverse reactions associated with icosapent ethyl were bleeding (11.8%), peripheral oedema (7.8%), atrial fibrillation (5.8%), constipation (5.4%), musculoskeletal pain (4.3%), gout (4.3%) and rash (3.0%).1 A larger percentage of patients in the icosapent ethyl group, than in the placebo group were hospitalised for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06).1,2
Professor Gabriel Steg, co-author of the REDUCE-IT study and Chief, Department of Cardiology at Hôpital Bichat, Paris, commented, “The REDUCE-IT study shows icosapent ethyl could reduce CV events and has the potential to change the way residual cardiovascular risk is treated. This authorisation of icosapent ethyl can make a difference to patients who are at high-risk of suffering from a heart attack or stroke. Eligible patients can be confident we have a new treatment that is backed by evidence-based data and European guideline recommendations.”
The publication of this research has led to icosapent ethyl being recommended for use in studied high-risk statin treated patients identified by moderately elevated triglycerides by 15 global medical societies around the world including the European Society of Cardiology and the European Atherosclerosis Society.4,5
Strokes and heart attacks caused by cardiovascular disease (CVD) are the most common cause of death in Europe.6 The economic burden of CVD in the European Union exceeds €210 billion a year and is expected to increase over the coming decades.7
The marketing authorisation is also timely in the wake of the COVID-19 pandemic, which has resulted in the reprioritisation of clinical resources, leaving patients with serious cardiovascular disease to delay much needed medical help.7 Preventative care is needed for at-risk patients with cardiovascular disease, including LDL-cholesterol management and additional treatments for statin-treated patients with residual cardiovascular risk, identified by elevated triglycerides to address their unmet need.
Amarin’s President and Chief Executive Officer John Thero added, “We began developing icosapent ethyl in Europe more than a decade ago. We are very grateful to the many patients and physicians who contributed to the development and clinical study of icosapent ethyl. Icosapent ethyl can help to reduce strokes, heart attacks and other major cardiovascular events in high-risk patients across Europe. We are dedicated to a rethinking of cardiovascular disease risk reduction in Europe with an emphasis on preventative care. We will work tirelessly throughout Europe to make icosapent ethyl available to all patients who may benefit from this therapy.”
* The Great Britain Marketing Authorisation approves icosapent ethyl in England, Scotland and Wales. Under the Brexit Northern Ireland agreement, the European centralised marketing authorisation will cover Northern Ireland.
Notes to Editors
Key clinical effects of icosapent ethyl on time to first occurrence of major adverse cardiovascular events are included in Summary of Product Characteristics1 and presented below.
Effect of icosapent ethyl on time to first occurrence of cardiovascular events in patients with elevated triglyceride levels and cardiovascular disease or diabetes and other risk Table 1 factors in REDUCE-IT.1,2
|Icosapent ethyl||Placebo||Icosapent ethyl vs Placebo|
|N = 4089
|N = 4090 n (%)||Hazard Ratio
|Primary composite endpoint|
|Cardiovascular death, myocardial infarction, stroke, coronary revascularisation, hospitalisation for unstable angina (5-point MACE)||705
|Key secondary composite endpoint|
|Cardiovascular death, myocardial infarction, stroke (3-point MACE)||459
|Other secondary endpoints|
|Death by any cause||274
|Fatal or non-fatal myocardial infarction||250
|Fatal or non-fatal stroke||98
|Emergent or urgent coronary revascularization||216
|Hospitalisation for unstable angina||108
 Cardiovascular death includes adjudicated cardiovascular deaths and deaths of undetermined causality.
 Death by any cause, or total mortality, is not a component of either the primary composite endpoint or key secondary composite endpoint.
 The predefined composite secondary endpoint included emergent or urgent revascularisation (p<0.0001); coronary revascularisations is the composite of all revascularisation and was predefined as a tertiary endpoint.
 Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalisation.
Amarin is a rapidly growing, innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management. Amarin’s subsidiary company, Amarin Pharmaceutical Ireland Ltd (APIL) is the Great Britain Marketing Authorisation holder.
This press release contains forward-looking statements, including statements about the potential of icosapent ethyl to favorably affect cardiovascular risk in appropriate patients, expectations at Amarin that icosapent ethyl will be part of a new era for cardiovascular risk reduction in Europe, and plans at Amarin to make icosapent ethyl available to patients in need. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties that may individually or together impact the matters herein and cause actual results, events and performance to differ materially from such forward looking statements. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: delays due to COVID-19 restrictions, later arising data, regulatory reviews and pricing assessments, and the successful implementation of commercialization plans. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent annual report on Form 10-K. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Adverse events should be reported.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to Amarin Corporation by e-mail to [email protected]
Amarin Contact Information
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Date of preparation: May 2021
Job number: EUR-NP-00033.
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1. Summary of Product Characteristics Vazkepa® – April 2021 https://ec.europa.eu/health/documents/community-register/2021/20210326150935/anx_150935_en.pdf
2. Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.
3. Union Register of medicinal products - Public health - European Commission. https://ec.europa.eu/health/documents/community-register/html/h1524.htm Accessed April 22nd, 2021.
4. Amarin Data on File
5. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019;290:140-205.
6. ESC Cardiovascular Realities 2020 - Flipsnack.https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html Accessed April 22nd, 2021.
7. Fersia O, Bryant S, Nicholson R, et al. The impact of the COVID-19 pandemic on cardiology services. Heart. 2020;7:1359.