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Amarin Receives European Commission (EC) Approval for VAZKEPA to Reduce Cardiovascular Risk

Published: 2021-03-30 10:24:00 ET
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Marks first and only EC-approved treatment to reduce cardiovascular risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT® 1, 2

DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced that following a review and approval recommendation by the European Medicines Agency (EMA), the European Commission (EC) has approved the marketing authorization application for VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events in high-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.

Amarin’s icosapent ethyl was approved for cardiovascular risk reduction by the U.S. Food and Drug Administration (FDA) in December 2019 and is marketed in the U.S. under the brand name, VASCEPA®.

“The approval of VAZKEPA marks a significant milestone for high-risk cardiovascular patients in Europe as it offers the first and only EC-approved therapy to reduce cardiovascular risk in high-risk statin-treated patients who have elevated triglycerides,” said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin. “We look forward to launching VAZKEPA in Europe as it is an exciting opportunity for Amarin to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event.”

The EC approval for VAZKEPA is based on over a decade of development and testing of icosapent ethyl, including efficacy and safety data from the REDUCE-IT® cardiovascular outcomes study.2 REDUCE-IT evaluated more than 8,000 high risk patients who despite having their cholesterol levels well controlled by statin therapy remained at significant risk of heart attack, stroke, or other major adverse cardiovascular events (MACE), including death. As published, patients in the REDUCE-IT study had a median follow-up period of nearly five years. Results from this study, in which all patients remained treated with statins (and with other contemporary therapies) and where half the patients received icosapent ethyl and the other half received placebo, demonstrated a 25% relative risk reduction (p1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).

  • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
  • Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
  • 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 Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT

     VASCEPAPlaceboVASCEPA vs Placebo
    N = 4089n (%)Incidence Rate (per 100 patient years)N = 4090n (%)Incidence Rate (per 100 patient years)Hazard Ratio(95% CI)
    Primary composite endpoint
    Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)705(17.2)4.3901(22.0)5.70.75(0.68, 0.83)
    Key secondary composite endpoint
    Cardiovascular death, myocardial infarction, stroke (3-point MACE)459(11.2)2.7606(14.8)3.70.74(0.65, 0.83)
    Other secondary endpoints
    Fatal or non-fatal myocardial infarction250(6.1)1.5355(8.7)2.10.69(0.58, 0.81)
    Emergent or urgent coronary revascularization216(5.3)1.3321(7.8)1.90.65(0.55, 0.78)
    Cardiovascular death [1]174(4.3)1.0213(5.2)1.20.80(0.66, 0.98)
    Hospitalization for unstable angina [2]108(2.6)0.6157(3.8)0.90.68(0.53, 0.87)
    Fatal or non-fatal stroke98(2.4)0.6134(3.3)0.80.72(0.55, 0.93)
    [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality.[2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

    FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATIONCAN BE FOUND AT WWW.VASCEPA.COM.

    Forward-Looking Statements This press release contains forward-looking statements, including statements about the potential of VAZKEPA (known as VASCEPA in the United States) to favorably affect cardiovascular risk in appropriate patients, to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event, with respect to Amarin being well-positioned for a successful European launch and related to the potential for extended patent protection. 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: events that could impact future regulatory assessment by the European Commission, such as delays due to COVID-19 restrictions, later arising data, regulatory reviews and pricing assessments, and the successful implementation of commercialization plans or other information, events that could interfere with the grant or issuance of a patent, continued validity or enforceability of a patent; uncertainties associated with litigation generally and patent litigation specifically; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; and uncertainties associated generally with research and development and regulatory submissions, reviews, action dates and approvals. 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.

    Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Amarin Contact InformationInvestor Inquiries:Investor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com (investor inquiries)

    Solebury Troutamarinir@troutgroup.com

    Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media inquiries)

    ____________________________

    1 Union Register of medicinal products - Public health - European Commission. https://ec.europa.eu/health/documents/community-register/html/h1524.htm. Accessed March 30, 2021.2 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 ESC Cardiovascular Realities 2020 by... - Flipsnack. https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html. Accessed March 30, 2021. 4 Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019;290:140-205. doi:10.1016/j.atherosclerosis.2019.08.014 5 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.6 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.

    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.

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    Source: Amarin Corporation plc