FDA delays decision on Vascepa for high triglycerides and schedules a review
The FDA has announced plans to hold an advisory panel review of Vascepa (icosapent ethyl) from Amarin, tentatively scheduled for November 14. Due to this surprise decision, the FDA is now not expected to rule on an expanded approval for Vascepa until December 2019, three months later than the late September PDUFA date anticipated under a priority review.
Amarin hopes to broaden the indication for Vascepa to include claims that the drug offers a benefit to heart health in a wider population. Results from a trial of more than 8,000 patients, called REDUCE-IT, first announced in autumn 2018, showed Vascepa could cut heart risk by a quarter versus placebo.
Comment: the REDUCE-IT study showed that Vascepa provided a statistically significant 30% risk reduction in total (first and subsequent) cardiovascular events compared to placebo in the statin-treated patient population studied in REDUCE-IT. These data were presented at the American College of Cardiology's (ACC) 68th Annual Scientific Session and published simultaneously in the Journal of the American College of Cardiology.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins