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Amarin Receives Nice Britain Advertising Authorization for VAZKEPA from the Medicines and Healthcare Merchandise Regulatory Company (MHRA) 1,2


VAZKEPA (icosapent ethyl) is the primary and solely approved therapy for its cardiovascular danger discount indication1,2,3

VAZKEPA authorization for Nice Britain follows current VAZKEPA authorization for European Union

DUBLIN, Eire and BRIDGEWATER, N.J., April 22, 2021 (GLOBE NEWSWIRE) — Amarin Company plc (NASDAQ: AMRN) in the present day introduced that the Medicines and Healthcare Merchandise Regulatory Company (MHRA) has granted a Advertising Authorization for VAZKEPA (icosapent ethyl) as a therapy to scale back the chance of cardiovascular occasions in excessive cardiovascular danger statin-treated grownup sufferers who’ve elevated triglycerides (≥150 mg/dL) and both established heart problems or diabetes, and at the least one extra cardiovascular danger issue. The Nice Britain Advertising Authorization for VAZKEPA applies to England, Scotland and Wales. Below the Brexit Northern Eire settlement, the European centralized advertising authorization for the European Union covers Northern Eire.

The MHRA’s license swiftly adopted the European Fee (EC) advertising authorization of icosapent ethyl for the European Union as introduced on March 30, 2021.3 Amarin’s understanding is that icosapent ethyl is among the many first merchandise to be submitted and licensed by way of the MHRA’s new ‘reliance’ route following the top of the Brexit transition interval. Icosapent ethyl has been recognized as a brand new lively substance with seemingly multi-factorial mechanisms of motion.1

The MHRA authorization for VAZKEPA is predicated on over a decade of growth and testing of icosapent ethyl, together with efficacy and security information from the REDUCE-IT® cardiovascular outcomes research.2 REDUCE-IT evaluated greater than 8,000 high-risk sufferers who regardless of having their levels of cholesterol effectively managed by statin remedy remained at vital danger of coronary heart assault, stroke, or different main antagonistic cardiovascular occasions (MACE), together with loss of life. As revealed, sufferers within the REDUCE-IT research had a median follow-up interval of practically 5 years. Outcomes from this research, during which all sufferers remained handled with statins (and with different up to date therapies) and the place half the sufferers acquired icosapent ethyl and the opposite half acquired placebo, demonstrated a 25% relative danger discount (p<0.001) within the first prevalence of MACE within the intent-to-treat affected person inhabitants with use of icosapent ethyl (4 grams every day) in contrast with placebo.

Professor Gabriel Steg, M.D., Chief, Division of Cardiology at Hôpital Bichat, Paris, commented, “The REDUCE-IT research reveals icosapent ethyl might scale back CV occasions and has the potential to alter the best way residual cardiovascular danger is handled. This authorization of icosapent ethyl could make a distinction to sufferers who’re at high-risk of affected by a coronary heart assault or stroke. Eligible sufferers could be assured we now have a brand new therapy that’s backed by evidence-based information and European guideline suggestions.”

The publication of this analysis has led to icosapent ethyl being advisable to be used in high-risk statin-treated sufferers recognized by reasonably elevated triglycerides by 15 world medical societies all over the world together with the European Society of Cardiology and the European Atherosclerosis Society.4

Cardiovascular danger (CVD) is likely one of the main causes of loss of life in the UK, with coronary heart and circulatory ailments inflicting greater than 1 / 4 (27%) of all deaths within the UK, which is greater than 160,000 deaths every year.5

The advertising authorization can be well timed within the wake of the COVID-19 pandemic, which has resulted within the reprioritization of medical assets, typically leaving sufferers with critical heart problems to delay a lot wanted medical assist.6 Preventative care is required for at-risk sufferers with heart problems, together with LDL-cholesterol administration and extra therapies for statin-treated sufferers with residual cardiovascular danger, recognized by elevated triglycerides and different danger components, to deal with their unmet want.

“Icosapent ethyl has been serving to to scale back strokes, coronary heart assaults and different main cardiovascular occasions in high-risk sufferers in the USA,” acknowledged John Thero, president and chief govt officer of Amarin. “We’re devoted to the rethinking of heart problems danger discount throughout Europe with an emphasis on preventative care. Amarin will work tirelessly all through Europe to make icosapent ethyl out there to all sufferers who might profit from this necessary remedy.”

As well as, the corporate introduced that subsequent to the advertising authorization by the EC, the Norwegian Medicines Company knowledgeable Amarin of its advertising authorization for VAZKEPA in Norway.

Data relating to Amarin’s plans for commercialization and securing market entry in Europe and the UK could be discovered within the FAQ part underneath investor relations at www.amarincorp.com.

About Amarin
Amarin is an progressive pharmaceutical firm main a brand new paradigm in heart problems administration. From our scientific analysis basis to our deal with medical trials, and now our business growth, we’re evolving and rising quickly. Amarin has workplaces in Bridgewater, New Jersey in the USA, Dublin in Eire, and Zug in Switzerland in addition to business companions and suppliers all over the world. We’re dedicated to rethinking cardiovascular danger by way of the development of scientific understanding of the affect on society of serious residual danger that exists past conventional therapies, comparable to statins for ldl cholesterol administration.

About Cardiovascular Danger
Heart problems is the primary reason behind loss of life on the earth. In the USA alone, heart problems ends in 859,000 deaths per yr.7 And the variety of deaths in the USA attributed to heart problems continues to rise. As well as, in the USA there are 605,000 new and 200,000 recurrent coronary heart assaults per yr (roughly 1 each 40 seconds). Stroke charges are 795,000 per yr (roughly 1 each 40 seconds), accounting for 1 of each 19 U.S. deaths. In combination, in the USA alone, there are greater than 2.4 million main antagonistic cardiovascular occasions per yr from heart problems or, on common, 1 each 13 seconds.

Controlling unhealthy ldl cholesterol, also referred to as LDL-C, is one method to scale back a affected person’s danger for cardiovascular occasions, comparable to coronary heart assault, stroke or loss of life. Nevertheless, even with the achievement of goal LDL-C ranges, tens of millions of sufferers nonetheless have vital and chronic danger of cardiovascular occasions, particularly these sufferers with elevated triglycerides. Statin remedy has been proven to manage LDL-C, thereby lowering the chance of cardiovascular occasions by 25-35%.8 Important cardiovascular danger stays after statin remedy. Folks with elevated triglycerides have 35% extra cardiovascular occasions in comparison with folks with regular (in vary) triglycerides taking statins.9,10,11

About REDUCE-IT®
REDUCE-IT was a world cardiovascular outcomes research designed to guage the impact of VASCEPA in grownup sufferers with LDL-C managed to between 41-100 mg/dL (median baseline 75 mg/dL) by statin remedy and varied cardiovascular danger components together with persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and both established heart problems (secondary prevention cohort) or diabetes mellitus and at the least one different cardiovascular danger issue (main prevention cohort).

REDUCE-IT, performed over seven years and accomplished in 2018, adopted 8,179 sufferers at over 400 medical websites in 11 international locations with the most important variety of websites positioned inside the USA. REDUCE-IT was performed based mostly on a particular protocol evaluation settlement with FDA. The design of the REDUCE-IT research was revealed in March 2017 in Scientific Cardiology.7 The first outcomes of REDUCE-IT had been revealed in The New England Journal of Drugs in November 2018.2 The entire occasions outcomes of REDUCE-IT had been revealed within the Journal of the American School of Cardiology in March 2019.8 These and different publications could be discovered within the R&D part on the corporate’s web site at www.amarincorp.com.

About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription therapy accepted by the U.S. Meals and Drug Administration (FDA) comprised solely of the lively ingredient, icosapent ethyl (IPE), a novel type of eicosapentaenoic acid. VASCEPA was launched in the USA in January 2020 as the primary and solely drug accepted by the U.S. FDA for therapy of the studied high-risk sufferers with persistent cardiovascular danger after statin remedy. VASCEPA was initially launched in the USA in 2013 based mostly on the drug’s preliminary FDA accepted indication to be used as an adjunct remedy to eating regimen to scale back triglyceride ranges in grownup sufferers with extreme (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million instances. VASCEPA is roofed by most main medical insurance coverage. Along with the USA, VASCEPA is accepted and offered in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 advertising authorization was granted to icosapent ethyl within the European Union for the discount of danger of cardiovascular occasions in sufferers at excessive cardiovascular danger, underneath the model identify VAZKEPA.

Indications and Limitation of Use (in the USA)
VASCEPA is indicated:

  • As an adjunct to maximally tolerated statin remedy to scale back the chance of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in grownup sufferers with elevated triglyceride (TG) ranges (≥ 150 mg/dL) and

  • As an adjunct to eating regimen to scale back TG ranges in grownup sufferers with extreme (≥ 500 mg/dL) hypertriglyceridemia.

The impact of VASCEPA on the chance for pancreatitis in sufferers with extreme hypertriglyceridemia has not been decided.

Vital Security Data

  • VASCEPA is contraindicated in sufferers with recognized hypersensitivity (e.g., anaphylactic response) to VASCEPA or any of its elements.

  • VASCEPA was related to an elevated danger (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was better in sufferers with a earlier historical past of atrial fibrillation or atrial flutter.

  • It isn’t recognized whether or not sufferers with allergy symptoms to fish and/or shellfish are at an elevated danger of an allergic response to VASCEPA. Sufferers with such allergy symptoms ought to discontinue VASCEPA if any reactions happen.

  • VASCEPA was related to an elevated danger (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was better in sufferers receiving concomitant antithrombotic drugs, comparable to aspirin, clopidogrel or warfarin.

  • Frequent antagonistic reactions within the cardiovascular outcomes trial (incidence ≥3% and ≥1% extra frequent than placebo): musculoskeletal ache (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).

  • Frequent antagonistic reactions within the hypertriglyceridemia trials (incidence >1% extra frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal ache (1% vs 0.3%).

  • Opposed occasions could also be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.

  • Sufferers receiving VASCEPA and concomitant anticoagulants and/or anti-platelet brokers ought to be monitored for bleeding.

Key medical results of VASCEPA on main antagonistic cardiovascular occasions are included within the Scientific Research part of the prescribing data for VASCEPA as set forth beneath:

Impact of VASCEPA on Time to First Prevalence of Cardiovascular Occasions in Sufferers with
Elevated Triglyceride ranges and Different Danger Elements for Cardiovascular Illness in REDUCE-IT

VASCEPA

Placebo

VASCEPA
vs Placebo

N = 4089
n (%)

Incidence
Charge

(per 100
affected person years)

N = 4090
n (%)

Incidence
Charge

(per 100
affected person years)

Hazard Ratio (95% CI)

Major composite endpoint

Cardiovascular loss of life, myocardial
infarction, stroke, coronary
revascularization, hospitalization for
unstable angina (5-point MACE)

705
(17.2)

4.3

901
(22.0)

5.7

0.75
(0.68, 0.83)

Key secondary composite endpoint

Cardiovascular loss of life, myocardial
infarction, stroke (3-point MACE)

459
(11.2)

2.7

606
(14.8)

3.7

0.74
(0.65, 0.83)

Different secondary endpoints

Deadly or non-fatal myocardial infarction

250
(6.1)

1.5

355
(8.7)

2.1

0.69
(0.58, 0.81)

Emergent or pressing coronary revascularization

216
(5.3)

1.3

321
(7.8)

1.9

0.65
(0.55, 0.78)

Cardiovascular loss of life [1]

174
(4.3)

1.0

213
(5.2)

1.2

0.80
(0.66, 0.98)

Hospitalization for unstable angina [2]

108
(2.6)

0.6

157
(3.8)

0.9

0.68
(0.53, 0.87)

Deadly or non-fatal stroke

98
(2.4)

0.6

134
(3.3)

0.8

0.72
(0.55, 0.93)

[1] Consists of adjudicated cardiovascular deaths and deaths of undetermined causality.
[2] Decided to be brought on by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

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

Ahead-Wanting Statements
This press launch accommodates forward-looking statements, together with statements in regards to the potential of VAZKEPA (generally known as VASCEPA in the USA) to favorably have an effect on cardiovascular danger in applicable sufferers and about making VAZKEPA out there all through Europe to sufferers who’re liable to a cardiovascular occasion. These forward-looking statements will not be guarantees or ensures and contain substantial dangers and uncertainties which will individually or collectively affect the issues herein and trigger precise outcomes, occasions and efficiency to vary materially from such forward-looking statements. Among the many components that might trigger precise outcomes to vary materially from these described or projected herein embody the next: occasions that might affect future regulatory evaluation, comparable to delays resulting from COVID-19 restrictions, later arising information, regulatory opinions and pricing assessments, and the profitable implementation of commercialization plans or different data, occasions that might intrude with the grant or issuance of a patent, continued validity or enforceability of a patent; uncertainties related to litigation typically and patent litigation particularly; Amarin’s capability typically to keep up satisfactory patent safety and efficiently implement patent claims towards third events; and uncertainties related typically with analysis and growth and regulatory submissions, opinions, motion dates and approvals. An extra listing and outline of those dangers, uncertainties and different dangers related to an funding in Amarin could be present in Amarin’s filings with the U.S. Securities and Change Fee, together with its most up-to-date annual report on Type 10-Okay. Current and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof. Amarin undertakes no obligation to replace or revise the knowledge contained on this press launch, whether or not on account of new data, future occasions or circumstances or in any other case.

Availability of Different Data About Amarin
Traders and others ought to observe that Amarin communicates with its buyers and the general public utilizing the corporate web site (www.amarincorp.com), the investor relations web site (investor.amarincorp.com), together with however not restricted to investor shows and investor FAQs, Securities and Change Fee filings, press releases, public convention calls and webcasts. The knowledge that Amarin posts on these channels and web sites might be deemed to be materials data. Because of this, Amarin encourages buyers, the media, and others concerned with Amarin to evaluate the knowledge that’s posted on these channels, together with the investor relations web site, frequently. This listing of channels could also be up to date now and again on Amarin’s investor relations web site and should embody social media channels. The contents of Amarin’s web site or these channels, or another web site that could be accessed from its web site or these channels, shall not be deemed integrated by reference in any submitting underneath the Securities Act of 1933.

Amarin Contact Data
Investor Inquiries:
Investor Relations
Amarin Company plc
In U.S.: +1 (908) 719-1315
IR@amarincorp.com (investor inquiries)

Solebury Trout
amarinir@troutgroup.com

Media Inquiries:
Communications
Amarin Company plc
In U.S.: +1 (908) 892-2028
PR@amarincorp.com (media inquiries)

AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are logos of Amarin Prescription drugs Eire Restricted. VAZKEPA is a registered trademark in Europe and different international locations and areas and is pending registration in the USA.

1Abstract of Product Traits Vazkepa – April 2021 https://ec.europa.eu/well being/paperwork/community-register/2021/20210326150935/anx_150935_en.pdf
2 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Danger Discount with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.
3 Union Register of medicinal merchandise – Public well being – European Fee. https://ec.europa.eu/well being/paperwork/community-register/html/h1524.htm. Accessed April 22, 2021.
4 2019 ESC/EAS tips for the administration of dyslipidaemias: Lipid modification to scale back cardiovascular danger. Atherosclerosis. 2019;290:140-205.
5 BHF/College of Birmingham calculated charges in partnership with UK statistical businesses: ONS/NRS/NISRA (2016-18 information)
6 Fersia O, Bryant S, Nicholson R, et al. The affect of the COVID-19 pandemic on cardiology companies. Coronary heart. 2020;7:1359.
7 American Coronary heart Affiliation. Coronary heart Illness and Stroke Statistics—2020 Replace: A Report From the American Coronary heart Affiliation. Circulation. 2020;141:e139–e596.
8 Ganda OP, Bhatt DL, Mason RP, et al. Unmet want for adjunctive dyslipidemia remedy in hypertriglyceridemia administration. J Am Coll Cardiol. 2018;72(3):330-343.
9 Budoff M. Triglycerides and triglyceride-rich lipoproteins within the causal pathway of heart problems. Am J Cardiol. 2016;118:138-145.
10 Toth PP, Granowitz C, Hull M, et al. Excessive triglycerides are related to elevated cardiovascular occasions, medical prices, and useful resource use: An actual-world administrative claims evaluation of statin-treated sufferers with excessive residual cardiovascular danger. J Am Coronary heart Assoc. 2018;7(15):e008740.
11 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic heart problems – New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
12 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Discount of Cardiovascular Occasions with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
13 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Discount in first and complete ischemic occasions with icosapent ethyl throughout baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.

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