Amarin Receives Positive CHMP Opinion for Icosapent Ethyl for Cardiovascular Risk Reduction
January 29 2021 - 12:51PM
Amarin Corporation plc (NASDAQ:AMRN) today announced that in
response to Amarin’s Marketing Authorisation Application
submission, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion, recommending that a marketing authorisation be
granted to icosapent ethyl in the European Union for the reduction
of risk of cardiovascular events in patients at high cardiovascular
risk, under the brand name
VAZKEPA®. The CHMP
recommendation is now expected to be reviewed by the European
Commission, which has the authority to approve medicines for
marketing in the European Union. A decision by the European
Commission is expected to take place within 67 days of the CHMP
opinion.
“We thank the EMA for its thoughtful review of
our application and concluding it in a timely manner despite the
challenges imposed by COVID-19,” said Steven Ketchum, senior vice
president, president of R&D and chief scientific officer of
Amarin. “This positive CHMP opinion is a significant milestone for
Amarin, taking us one step closer to making this important therapy
available to millions of patients in the European Union at high
risk of cardiovascular events such as heart attacks and strokes. We
are dedicated to supporting a rethinking of cardiovascular disease
risk reduction in Europe with further emphasis on preventative
care.”
The CHMP opinion is based on over a decade of
development and testing of icosapent ethyl, including data from the
REDUCE-IT® cardiovascular outcomes study. 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 by
statins (and by other contemporary therapies) and where half the
patients received icosapent ethyl and the other half received
placebo, demonstrated a 25% relative risk reduction (p<0.001) in
the first occurrence of MACE in the intent-to-treat patient
population with use of icosapent ethyl (4 grams daily) compared
with placebo.
Based on communications with the EMA we expect
the indication language to be generally consistent with the
following:
That marketing authorisation be granted to
icosapent ethyl to reduce the risk of cardiovascular events in
adult statin-treated patients at high cardiovascular risk with
elevated triglycerides (≥150 mg/dL), and
- established cardiovascular disease,
or
- diabetes, and at least one other
cardiovascular risk factor.
Ten years of market protection is expected to be granted in the
European Union as part of a European Commission approval of the
pending application. In addition, pending patent applications
related to the REDUCE-IT study have the potential to extend
exclusivity in Europe into 2039.
For more information about the CHMP announcement visit the EMA
website (this link will take you to an external website)
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-29-january-2021
About Amarin 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.
Promotion DisclaimerThis press
release is intended for investor relations purposes. Icosapent
ethyl is not approved for marketing or sale in the European Union
and nothing in this press release is intended to promote such
use.
Forward-Looking Statements This
press release contains forward-looking statements, including
statements about expectation for further regulatory review, the
expected timing thereof, anticipated label language, anticipated
grants of regulatory exclusivity and the potential for patent
issuances and 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 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 quarterly report on Form 10-Q. 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.
Amarin Contact
InformationInvestor Inquiries:Investor
RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315
IR@amarincorp.com (investor inquiries)
Solebury Troutamarinir@troutgroup.com
US Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028 PR@amarincorp.com (media inquiries)
Europe Media Inquiries:Liam
EnglishEurope CommunicationsAmarin Corporation plc+44 (0) 750 500
8787media@amarincorp.eu (media inquiries)
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