Amarin finally receives label expansion for Vascepa, which can now be marketed to patients with Triglyceride levels of greater or equal to 150mg/dl and existing Cardiovascular Disease or Diabetes Mellitus plus two other risk factors for CVD. In this video, I go through what I think is the potential market for this drug and the company’s valuation. I also talk about a number of other companies that had updates at ASH2019 or around that time, including BLUE, FATE, DTIL, KOD, SRPT, SNY.
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Hey everyone! In this video, I discuss the relationship history between Amarin and the FDA regarding their EPA medication (Vascepa) for the lowering of triglycerides. I believe the difficulty #AMRN has had with the FDA in the past has made the market concerned about Vascepa’s future given recent announcement of an advisory committee meeting for label expansion of Vascepa. I also talk about Sarepta, Novartis and Gilead. Thanks for watching!
Amarin recently published data from their REDUCE-IT cardiovascular outcomes trial. Their EPA medicine, Vascepa, showed a 25% relative risk reduction compared to placebo. EPA is an omega-3 fatty acid that previously showed a 19% relative risk reduction in cardiovascular outcomes in a Japanese study (JELIS, 2007). Amarin saw a hazard ratio of 0.75 in their primary endpoint, which evaluated cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina. In this video, I go through two critiques of the study:
1) Lack of mechanistic insight
2) Mineral oil use in the placebo group
I believe Vascepa is likely to get FDA approval for the indication of reducing cardiovascular disease in patients with over 150mg/dl Triglycerides on statin therapy.
This is not investment advice, do your own due diligence.