Doubt if it is "for the first time." How long did clinical trial of NVS last vis a vis Marine(FDA-approved indication), Anchor and 8000+ patient Reduce-It trials of Amarin for Vascepa? I have been prescribed Vascepa, off-label, since April 1, 2013. My latest EPA/AA ratio is 1.7. I have read not read NEJM yet---does NVS report comparable ratios for anti-inflammatory effect?
BTW, I co-pay $9/month for my off-label prescription of Vascepa.
IDMC recommended the R-I trial continue, as planned, 2 weeks ago.