Amarin (AMRN) Reaches Agreement for REDUCE-IT Trial
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Amarin Corporation plc (Nasdaq: AMRN) has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) agreement for the design of the previously described cardiovascular outcomes study of AMR101 formally titled REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial).
Amarin previously announced that it achieved the primary endpoints of two Phase 3 studies of AMR101, both of which were conducted under separate SPAs.
Consistent with prior comments, Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion. The Company anticipates that if, as intended, it commences Outcomes study activities in 2011 that it will be positioned to achieve approximately 50% enrollment before the end of 2012.
Amarin previously announced that it achieved the primary endpoints of two Phase 3 studies of AMR101, both of which were conducted under separate SPAs.
Consistent with prior comments, Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion. The Company anticipates that if, as intended, it commences Outcomes study activities in 2011 that it will be positioned to achieve approximately 50% enrollment before the end of 2012.
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