Optimistic opinion relies on intensive medical research outcomes, together with outcomes of the REDUCE-IT® cardiovascular outcomes research
European Fee choice on the Advertising Authorisation Software anticipated in April 2021
DUBLIN, Eire and BRIDGEWATER, N.J., Jan. 29, 2021 (GLOBE NEWSWIRE) — Amarin Company plc (NASDAQ:AMRN) in the present day introduced that in response to Amarin’s Advertising Authorisation Software submission, the Committee for Medicinal Merchandise for Human Use (CHMP) of the European Medicines Company (EMA) has adopted a constructive opinion, recommending {that a} advertising and marketing authorisation be granted to icosapent ethyl within the European Union for the discount of threat of cardiovascular occasions in sufferers at excessive cardiovascular threat, underneath the model title VAZKEPA®.
The CHMP advice is now anticipated to be reviewed by the European Fee, which has the authority to approve medicines for advertising and marketing within the European Union. A call by the European Fee is predicted to happen inside 67 days of the CHMP opinion.
“We thank the EMA for its considerate evaluate of our utility and concluding it in a well timed method regardless of the challenges imposed by COVID-19,” mentioned Steven Ketchum, senior vice chairman, president of R&D and chief scientific officer of Amarin. “This constructive CHMP opinion is a big milestone for Amarin, taking us one step nearer to creating this essential remedy accessible to thousands and thousands of sufferers within the European Union at excessive threat of cardiovascular occasions comparable to coronary heart assaults and strokes. We’re devoted to supporting a rethinking of heart problems threat discount in Europe with additional emphasis on preventative care.”
The CHMP opinion relies on over a decade of growth and testing of icosapent ethyl, together with information from the REDUCE-IT® cardiovascular outcomes research. REDUCE-IT evaluated greater than 8,000 excessive threat sufferers who regardless of having their levels of cholesterol effectively managed by statin remedy remained at vital threat of coronary heart assault, stroke, or different main antagonistic cardiovascular occasions (MACE), together with demise. As revealed, sufferers within the REDUCE-IT research had a median follow-up interval of almost 5 years. Outcomes from this research, by which all sufferers remained handled by statins (and by different up to date therapies) and the place half the sufferers acquired icosapent ethyl and the opposite half acquired placebo, demonstrated a 25% relative threat discount (p<0.001) within the first incidence of MACE within the intent-to-treat affected person inhabitants with use of icosapent ethyl (4 grams each day) in contrast with placebo.
Primarily based on communications with the EMA we count on the indication language to be usually per the next:
That advertising and marketing authorisation be granted to icosapent ethyl to scale back the danger of cardiovascular occasions in grownup statin-treated sufferers at excessive cardiovascular threat with elevated triglycerides (≥150 mg/dL), and
- established heart problems, or
- diabetes, and not less than one different cardiovascular threat issue.
Ten years of market safety is predicted to be granted within the European Union as a part of a European Fee approval of the pending utility. As well as, pending patent functions associated to the REDUCE-IT research have the potential to increase exclusivity in Europe into 2039.
For extra details about the CHMP announcement go to the EMA web site (this hyperlink will take you to an exterior web site) https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-29-january-2021
About Amarin
Amarin is a quickly rising, modern 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 enlargement, we’re evolving and rising. In 2009, Amarin had fewer than twenty staff. At this time, with places of work in Bridgewater, New Jersey in the US, Dublin in Eire, and Zug in Switzerland, Amarin has roughly 1,000 staff and business companions and suppliers world wide. We’re dedicated to rethinking cardiovascular threat by way of the development of scientific understanding of the influence on society of serious residual threat that exists past conventional therapies, comparable to statins for ldl cholesterol administration.
Promotion Disclaimer
This press launch is meant for investor relations functions. Icosapent ethyl will not be authorised for advertising and marketing or sale within the European Union and nothing on this press launch is meant to advertise such use.
Ahead-Wanting Statements
This press launch accommodates forward-looking statements, together with statements about expectation for additional regulatory evaluate, the anticipated timing thereof, anticipated label language, anticipated grants of regulatory exclusivity and the potential for patent issuances and safety. These forward-looking statements aren’t guarantees or ensures and contain substantial dangers and uncertainties which will individually or collectively influence the issues herein and trigger precise outcomes, occasions and efficiency to vary materially from such ahead wanting statements. Among the many elements that might trigger precise outcomes to vary materially from these described or projected herein embody the next: occasions that might influence future regulatory evaluation by the European Fee, comparable to delays because of COVID-19 restrictions, later arising information or different data, occasions that might intervene with the grant or issuance of a patent, continued validity or enforceability of a patent; uncertainties related to litigation usually and patent litigation particularly; Amarin’s capability usually to take care of sufficient patent safety and efficiently implement patent claims towards third events; and uncertainties related usually 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 will be present in Amarin’s filings with the U.S. Securities and Trade Fee, together with its most up-to-date quarterly report on Type 10-Q. Present and potential traders 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 because of new data, future occasions or circumstances or in any other case.
Amarin Contact Info
Investor Inquiries:
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Alina Kolomeyer
Communications
Amarin Company plc
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PR@amarincorp.com (media inquiries)
Europe Media Inquiries:
Liam English
Europe Communications
Amarin Company plc
+44 (0) 750 500 8787
media@amarincorp.eu (media inquiries)
