Omthera trials fish oil pill Epanova with statins, hoping for 2012 filing in high TG
This article was originally published in Scrip
Executive Summary
Omthera Pharmaceuticals continues to be optimistic that it is on track to file an NDA in 2012 with the US FDA for its prescription-grade omega-3 fatty acid candidate, Epanova, a novel formulation of free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), for treating patients with very high triglyceride levels (500mg/dL and above) – based on the EVOLVE trial. That pivotal Phase III trial is being conducted under a special protocol assessment (SPA) with the FDA, which outlines an agreed-upon trial protocol design, and top-line results are expected in the first half of 2012.