Amarin Announces First European Launch of VAZKEPA (icosapent ethyl) in Germany
DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the first European launch of VAZKEPA (icosapent ethyl) in Germany. VAZKEPA received marketing authorization from the European Commission in March 2021 and the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain in April 2021. VAZKEPA is indicated as a treatment to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk who have elevated triglycerides (= 150 mg/dL [= 1.7 mmol/L]) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.1
The European launch of VAZKEPA, beginning in Germany, is supported by more than a decade of evidence-based cardiovascular clinical outcomes research including the landmark REDUCE-IT® study, a groundbreaking study2 which established that VASCEPA®/VAZKEPA lowers the risk of a life-threatening heart attack or stroke by 25% when added to a statin in the targeted population. Importantly, VASCEPA/VAZKEPA has been included in the treatment guidelines for cardiovascular disease (CVD) prevention by the European Society of Cardiology, the European Association of Preventive Cardiology and the European Atherosclerosis Society, in addition to 17 other medical guidelines around the world.
The launch of VAZKEPA in Germany featured a scientific conference in Berlin titled, “New therapeutic strategies for residual CV risk management,” which highlighted the scientific underpinnings and clinical benefits of VASCEPA/VAZKEPA in reducing cardiovascular risk. The symposium was led by eleven internationally renowned cardiovascular specialists, was attended by more than 200 healthcare professionals from Germany and was live streamed to many more physicians across the continent. The event has been archived and is available to thousands of physicians across Europe.
Amarin’s president and chief executive officer, Karim Mikhail, stated, “The German launch is a historic moment for Amarin, as it is the first European country where VAZKEPA’s proven cardioprotective benefits are available to healthcare providers and patients. This is particularly important as CVD is the number one cause of death in Europe.” Mr. Mikhail added, “Our European launch marks a key milestone in our corporate growth strategy to bring the cardiovascular risk reduction benefits of VASCEPA/VAZKEPA to at-risk patients around the world. As Germany is the fourth largest global economy and there are more than 300,000 deaths due to CVD in Germany every year3, it represents both a significant market need and opportunity.”
Laurent Abuaf, recently appointed as senior vice president and president of Europe, further noted, “Throughout last year Amarin made great progress building the commercial infrastructure in Europe and has recruited and trained a talented team of nearly 200 professionals to execute VAZKEPA’s launch. We are especially pleased with our successful German launch event and look forward to executing our plans to launch VAZKEPA across multiple European countries before the end of 2022.” Mr. Abuaf continued, “Cardiovascular disease (CVD) is one of Europe’s biggest health crises, costing the European Union €210 billion a year,4 and resulting in 3.9 million deaths.5 Amarin has ambitious plans to tackle this growing healthcare burden by working in partnership with healthcare professionals across the continent to challenge the conventions surrounding CVD care.”
Amarin has already filed market access dossiers in five out of the ten planned “first wave” European country submissions. The dossiers were filed in Germany, the United Kingdom, France, Italy and Denmark and, over the next quarter, Amarin plans to submit the remaining five dossiers. The company is committed to bringing the benefits of VAZKEPA to as many patients in Europe as quickly as possible.
With its global headquarters in Ireland and a new commercial hub in Zug, Switzerland, Amarin has strong European roots and the infrastructure necessary to support the company’s plans to build a local commercial presence in all major European markets for a series of successful launches across the continent.
About Cardiovascular Risk
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.9 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.10,11,12
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.13 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.14 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.15 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
Indications and Limitation of Use (in the United States)
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
FOR FURTHER INFORMATION ABOUT THE SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) FOR VAZKEPA® IN EUROPE, PLEASE click here.
Availability of Other Information About Amarin
AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.
1 Summary of Product Characteristics Vazkepa – April 2021 https://ec.europa.eu/health/documents/community-register/2021/20210326150935/anx_150935_en.pdf. Accessed August 2021
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