STAT EXPERT ADVANTAGE CALL
Preparing for the Vascepa panel: Discussing Amarin's data before an (unexpected) advisory committee meetng

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Amarin was surprised — and its stock price fell — when the FDA announced it would schedule an advisory panel meeting on Nov. 14 to review the company’s application seeking an expansion of the Vascepa label, based on the cardiovascular risk reduction data that came out of the REDUCE-IT study.

If you haven’t already, don’t forget to register for October’s STAT Expert Advantage call, Preparing for the Vascepa panel: Discussing Amarin's data before an (unexpected) advisory committee meeting. STAT’s Adam Feuerstein will sit down with Dr. Robert Rosenson, director of cardiometabolic disorders at Mount Sinai, and professor of medicine at the Icahn School of Medicine, to:

• Review the data from Amarin’s REDUCE-IT study

• Dig into the controversies and unresolved questions that are likely to be addressed at the FDA advisory panel meeting on Nov. 14

• The expectations for Mirati’s KRAS inhibitor MRTX849, which will readout initial data in Q4

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(This isn’t the first time we’ve discussed Vascepa! We hosted our first STAT Expert Advantage call in July 2018 on how Vascepa was faring in the REDUCE-IT outcomes study. You can access the case study on that call here, or the full transcript here. We also did a followup call this year on the results and implications of the REDUCE-IT trial.)

ABOUT THE EXPERT

Dr. Robert Rosenson is director of cardiometabolic disorders at Mount Sinai, and professor of medicine at the Icahn School of Medicine. He currently manages 600 patients with hypertriglyceridemia, and has prescribed Vascepa to 60 patients. His research focuses on the effects of novel lipid-lowering therapy, inflammation, and rheology, and he has served as principal investigator on a number of studies funded by the National Institutes of Health, pharmaceutical-sponsored drug trials, and multicenter studies.