On October 29th, 2013 the FDA quietly announced it had determined that “High” triglyceride (TG) (blood fats) levels in the 200 - 499 mg/dL range are no longer considered risk factors for cardiovascular disease (CVD) or cardiovascular events (CVE). Specifically, the FDA stated in a letter to the Amarin Corporation, PLC that it “no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum TG levels below 500 mg/dL.”Read More
The EPA Drug Initiative, an organization made up of individual citizens committed to improving cardiac health in the United States and representing more than 1,200 supporters nationwide, submits this petition to request the Commissioner of Food and Drugs to overturn the FDA’s decision to rescind the Special Protocol Assessment for VASCEPA and to delay the PDUFA date for ANCHOR sNDA.Read More
It was mild curiosity that drew John Virgin and his son Bryce to the flashing lights and commotion of an accident scene near their home. In the back of John's mind was his older son, Grant, who had gone for a walk nearby minutes earlier.
Minutes earlier, the 16-year-old had been airlifted to a nearby trauma center after being struck by a hit-and-run driver. He had a long list of injuries: a torn aorta, a traumatic brain injury -- including skull fractures and bleeding throughout his brain -- compound bone fractures and spinal fractures. Seemingly endless bits of broken glass and gravel were embedded in his skin.
Fish oil is what the Virgin family believes ultimately -- dramatically -- altered his life course, and healed his brain.
Author: Stephanie Smith, CNNRead More
These extensive AMCP presentations explore the same trial data used by the FDA, but come to a very different conclusion for add-on to statin therapy and, specifically, Vascepa.
Evidence- and Guideline-Based Management of Hypertriglyceridemia
Hypertriglyceridemia and CVD Risk:
Significance, Relationship to Other Lipid Biomarkers, and Assessment
This article provides an in-depth review and analysis of the three clinical outcome trials, cited by the FDA as the reason for rescinding the ANCHOR SPA. It is intended to educate readers as to the adequacy and fairness of FDA’s review and whether their decision was justified based on the “substantial scientific issue” argument.Read More