Wednesday, August 31, 2016 10:01:57 AM
Buy, PT $4.50
Amarin Corporation (AMRN) REDUCE-IT Set for First Interim Readout in September
Key Takeaway AMRN has randomized its final patient for REDUCE-IT investigating Vascepa. The first interim analysis by the DMC is expected in Sep, which is slightly more honed than previous guidance (Sep/Oct previously). To reiterate, the bar to stop the trial for overwhelming efficacy is high (p<0.0076 to hit significance), we therefore expect the trial to continue as planned and we continue to model success on final analysis.
REDUCE-IT Set for First Interim Readout in September:
AMRN announced that it has randomized its final patient for the REDUCE-IT cardiovascular outcomes study investigating Vascepa, with 8,175 individual patients randomized. The first prespecified interim analysis by the DMC on ~60% of the target aggregate primary cardiovascular events is expected in September, which is slightly more honed than previous guidance (September/October previously). As we have previously stated, the bar to stop the trial for overwhelming efficacy on the primary endpoint at this interim is high (p<0.0076 to hit significance), and the company has stated that it would like to see certain secondary endpoints directionally favorable as well. We therefore expect the trial to continue as planned.
Second Interim Analysis Expected in Mid-2017:
Assuming REDUCE-IT continues through the first interim in September, the second prespecified interim analysis on 80% of the target aggregate primary events is expected in mid-2017 (expected to reach the 80% of events in H1 2017). The p-value to stop the trial for overwhelming efficacy at this interim is p<0.0220 for the primary endpoint, with certain secondary endpoints directionally favorable as well. At this time, we continue to expect a favorable outcome on final analysis where p<0.0422 is needed for success, expected in early 2018.
Recent AMRN News
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
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- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
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