Tag: Amarin

Amarin Receives Great Britain Marketing Authorization for VAZKEPA from the Medicines and Healthcare Products Regulatory Agency (MHRA) 1,2

VAZKEPA (icosapent ethyl) is the first and only authorized treatment for its cardiovascular risk reduction indication1,2,3 VAZKEPA authorization for Great Britain follows recent VAZKEPA authorization for European Union DUBLIN, Ireland and BRIDGEWATER, N.J., April 22, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN) today announced that the Medicines and […]

Amarin Commences Commercial Initiatives for VAZKEPA in European Union Following Recent Regulatory Approval for Cardiovascular Risk Reduction Indication

Reimbursement dossiers for first 10 countries to be filed in coming months 150 people hired and on-track to be deployed by mid-Q2 2021 supplemented by digital outreach and medical education programs with initial top priority on Germany VAZKEPA commercial launch in Germany planned for Q3 2021 DUBLIN, Ireland and BRIDGEWATER, […]

VASCEPA® (Icosapent Ethyl) Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in Analyses of Landmark REDUCE-IT® Study Presented at International Stroke Conference 2021

28% and 32% significant reductions in first and total strokes, respectively, demonstrated with VASCEPA compared to placebo, as well as reductions in first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke, in statin-treated patients with elevated cardiovascular risk Consistent reductions in overall stroke and in ischemic stroke […]

Amarin Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

Record Revenue of $614.1 Million and $167.3 Million for Full Year and Fourth Quarter 2020 Despite COVID-19 Impact Received Positive CHMP Opinion for VAZKEPA® in Europe and Continue to Advance Commercial Launch Plans for Europe Management to Host Conference Call Today at 7:30 a.m. ET DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. […]

Amarin Provides Update on VASCEPA® (Icosapent Ethyl) Regulatory Review Processes in Mainland China and Hong Kong

DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that its corporate partner in China, Edding, has progressed VASCEPA® (icosapent ethyl) into commencement of the regulatory review processes in Mainland China and Hong Kong. In Mainland China, the Chinese National Medical Products Administration […]

Amarin Receives Positive CHMP Opinion for Icosapent Ethyl for Cardiovascular Risk Reduction

Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT® cardiovascular outcomes study European Commission decision on the Marketing Authorisation Application expected in April 2021 DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 29, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that in response to Amarin’s […]

Amarin Expands Cardiovascular Risk Reduction Patent Infringement Lawsuit to Include Health Care Insurance Provider

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 25, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), announced today an expansion of the scope of its VASCEPA® (icosapent ethyl) cardiovascular (CV) risk reduction patent infringement lawsuit against Hikma Pharmaceuticals PLC to include a health care insurance provider in the United States, Health Net, […]

Amarin Provides Preliminary 2020 Results and 2021 Outlook

Unaudited 2020 Total Net Revenue Estimated to Be Approximately $610 Million, an Increase of Approximately 42% Compared with 2019 Completion of European Regulatory Review and Submission of China Regulatory Application for VASCEPA® (icosapent ethyl) Expected in Late January or February 2021 DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) […]