Amarin Corporation plc (ADR) (NASDAQ:AMRN) has announced that its REDUCE-IT cardiovascular analysis is set to continue as planned. This was after it review and recommendation by the Independent Data Monitoring Committee (DMC).
The company revealed in its announcement that things are proceeding as expected after the completion of the review process by the DMC. The review committee was carrying out a review of the safety analysis and the scheduled pre-specified interim efficacy for Amarin’s REDUCE-IT cardiovascular outcomes study. The review committee has recommended that the study should resume as planned without any changes.
Amarin has a lot riding on the REDUCE-IT cardiovascular study and the bar has been set quite high. This is because the trial marks the first prospective clinical trial of any therapy that involves a large patient population. The advantage is that the study stands to produce a high level of strong results due to a large number of cardiovascular events that might be obtained by continuing the study until the end.
“We are pleased that we are nearing completion of the REDUCE-IT study and thank the independent DMC members for their diligence in overseeing this important study,” stated Steven Ketchum, the Chief Scientific Officer of Amarin.
The company is expected to announce the final results of the study in Q2 or Q3 of 2018. The study involves 8,175 patients and is expected to determine whether Vascepa® (icosapent ethyl) treatment causes any significant reduction in major cardiovascular events. This is especially in patients who elevated triglyceride levels among other risk factors despite stabilized statin therapy.
The continuation recommendation by the DMC also represents the organization’s review of all the safety data that was provided. Safety reviews have been carried out multiple times every year ever since the launch of REDUCE-IT in December 2011 as part of the DMC charter and study protocol. More than 30,000 patients have been involved so far and the studies have led to years of research.
Amarin stock closed the latest trading session on Thursday at $3.16 after tanking by 3.07 percent compared to the value of the stock during the previous close.