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Preparing For the Panel: Discussing the Amarin's Vascepa Data Before Next Month's Unexpected Advisory Committee. (Including a survey of 25 cardiologists on their utilization pre and post REDUCE-IT!)

Ticker(s): AMRN

Who's the expert?

Name: Dr Pradeep Natarajan - MD | MMSc

Institution: Mass General | Harvard 

  • Director of Preventive Cardiology at Massachusetts General Hospital, Assistant Professor of Medicine at Harvard Medical School, and Associate Member of the Broad Institute of Harvard and MIT. 
  • Sees several patients with hypertriglyceridemia per week. (~1-5/week) and has prescribed Vascepa to 10-15 patients so far.
  • Leads a research laboratory focused on human genetic basis of atherosclerotic cardiovascular disease and plasma lipids.
  • Led the AHA podcast describing the 2018 cholesterol guidelines.

Interview Questions
Q1.

Questions to come from the STAT Reporting team.

Add yours below!

Added By: joe_mccann
Q2.

why do you think FDA called an adcom negating the priority review? how many of his current patients are taking Vascepa and does he think he would be increasing significantly post the label? 

Added By: user282f0563
Q3.

Could you discuss the scientific evidence for mineral oil affecting statin absorption?

Added By: sentiv
Q4.

Are you concerned at all about any data integrity issues with the REDUCE-IT trial, since it was a single, large, multi-year study conducted by a relatively small company?

Added By: sentiv
Q5.

Fact Checking Q3 above... It was 7.0 mg/dl, not 10. (and only an overall 5 mg/dl difference vs. active arm) From the NEJM paper: "The median change in LDL cholesterol level from baseline was an increase of 3.1% (2.0 mg per deciliter) in the icosapent ethyl group and an increase of 10.2% (7.0 mg per deciliter [0.18 mmol per liter]) in the placebo group — a 6.6% (5.0 mg per deciliter lower increase with icosapent ethyl than with placebo (P<0.001)."

Added By: user57e78d62
Q6.

Does  a 10mg/ dl rise in LDL in the placebo arm account for a substantial part of the difference bw placebo and Vascepa for outcomes?
Should they have used olive oil or corn oil as the placebo comparison?

Added By: usere74e51bb
Q7.

Does he think mineral oil accounts even in part for the REDUCE-IT results ? If so to what degree?

Added By: usere74e51bb
Q8.

What are your expectations with regard to the label expansion AMRN has requested?  Do you think the FDA will grant a broad label expansion?  What does that mean in your view? Do you believe that there will be substantial off-label prescriptions if the FDA does not authorize a broad label?

Added By: gkiernan
Q9.

Do you have any thoughts about the patent issues that have been raised in the ongoing litigation; or is this outside a doctor's paygrade?

Added By: gkiernan

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