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  • Thoughts On Befuddled FDA AdCom

    Vascepa was intended to reduce Trigs, which it did, safely and effectively, whether or not that translates to improved outcomes is unknown at this time.

    It should not be punished for not knowing the answer to outcomes, it does what it was asked to do, lowers Trigs and other Biomarkers, that is what it should be approved for with the label stating that no clinical outcome data is available to guarantee prevention of outcomes, but prevailing science feels that it is important to maintain healthy Trig and non-HDL-C levels.

    AACE was begging the panel to approve. It should be approved for this indication.

    Right now, Lovaza is the primary script written for ANCHOR patients, or off-label, and it comes with Atrial Fibrillation warnings and LDL-C raising concerns, neither of which Vascepa carries. Generic Lovaza could also be coming to market within a year or so, and that would likely be scripted to ANCHOR patients ahead of Vascepa for those Prescribers who don't understand all the details of the science and the warnings...

    Is this what you want to see FDA? You have to be out of your mind, and you ask "What if's" What if REDUCE-IT shows no benefit? Yeah, well how about THIS WHAT IF! What if REDUCE-IT shows dramatic benefit??

    WHAT IF REDUCE-IT SHOWS DRAMATIC BENEFIT!!! Then what do you say to all the Diabetic Mixed-Dyslipidemia patients who died while you held back a potential safe and effective LIFE SAVING THERAPY? WHAT IF?

    Use your head and listen to the prevailing science of the likes of the AACE who have thoroughly researched their field and have recommended therapy like Vascepa for those in need, those at risk.

    Disclosure: I am long AMRN.

    Oct 17 11:13 AM | Link | 4 Comments
  • Vascepa, ANCHOR, Outcomes, Oh My.

    Just some quick thoughts on the news of the day:

    People need to understand that the FDA often approves drugs based on "Prevailing Science", that is, the consensus among those in the field as to what is best for patients.

    Statins were approved in this way, they did not need Outcomes evidence that some say are a prerequisite for Vascepa. If Statins had to wait for evidence from Outcomes studies, many patients would have been left in the cold. Read about statin evolution here http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm082054.htm

    There are other examples of FDA approved drugs that have been approved on prevailing science and are still under going Outcomes studies.

    I think the Niaspan failed trial is what most in the field are holding up to Vascepa, vis-a-vis Trig reduction, HOWEVER, people need to OVERstand that these outcomes trials had patients with low baseline Trigs...

    It is more difficult to show improved Outcomes when your patients are ALREADY in a healthy zone... That is why Amarin PRd the REDUCE-IT enrolling milestone saying the intend to keep the BASELINE over 200mg/dL trigs.

    If you smoke 10 cigarettes a year and you cut it down to 5 cigarettes a year, you won't see much difference in overall Outcomes or adverse effects, If you cut 365 cigarettes a year to 182 a year, you would probably see a more healthy set of lungs. Apply the same to the baseline Trigs, a drop from 150mg/dL to 120mg/dL is not as important as 400 mg/dL to 320mg/dL.

    Disclosure: I am long AMRN.

    Oct 14 12:11 PM | Link | Comment!
  • EPA Goes Head To Head Against Ezetimibe (Zetia) And Outperforms The LDL-C Lowering Drug

    Researchers Yoshiaki Shintani & Tomohiro Kawasaki from the Shin-Koga Hospital, Kurume, Japan looked at the results from the JELIS study where both arms saw similar reductions in LDL-C yet the EPA supplemented (1.8g/day) arm saw a reduction in cardiovascular events. They wanted to explore these findings to see what else (besides LDL-C lowering) may play a factor in EPA's therapeutic benefit.

    Their findings were published in the Journal of the American College of Cardiology 2012;59(13s1):E1731-E1731. Can be found here: content.onlinejacc.org/article.aspx

    Their poster presentation is found here: www.google.com/url

    Here is their methodology,

    "A total of 51 lesions in 43 patients with suspected CAD (<75% stenosed vessels) and a LDL-C level of <160mg/dL were enrolled. The patients were randomly assigned to receive EPA or ezetimibe. Blood samples were collected to measure serum lipids and changes in coronary plaques were evaluated by MDCT at baseline and at a 1-year follow-up."

    So, we have 1 year of treatment with EPA or Zetia (Ezetimibe). For reference, Zetia is approved for "the reduction of elevated TOTAL-C, LDL-C, Apo B, and non-HDL-C", www.zetia.com/ezetimibe/zetia/hcp/

    This study simply looked at LDL-C numbers and the effects of EPA on coronary plaque stabilization compared to Zetia's performance in the same regard.

    Here is what they found after 1 year:

    (click to enlarge)

    The LDL-C did decrease in each group, however it was not stat significant in the EPA arm whereas the Zetia arm was stat significant. Almost predictably, the EPA/AA was drastically increased in the EPA treated patients compared to the Zetia arm. The EPA/AA ratio is seen as the balance or regulation between Anti-Inflammation and Inflammation in our body's immune response.

    Now look at the change in the Vessel area, Lumen area and Plaque area... The Lumen is the channel through which our blood flows, the greater the diameter of our Lumen, the easier it is for our blood to travel through our vasculature. The Plaque area correlates to the thickening of our arterial walls.

    EPA increased the size of the Lumen in treated patients by 8% whereas Zetia decreased the Lumen size by 16%, i.e. the channel narrowed. In line with those numbers, the Plaque area decreased in the EPA arm by 3.5% whereas it increased by 19.5% in the Zetia arm.

    The Soft Plaque volume, shown by the HU results, also improved more greatly in patients treated with EPA...

    This would suggest that 1 year duration is not enough to see the necessary improvement in Lumen area and Plaque reduction even if you reduce LDL-C. EPA seems to work independently of LDL-C where it is able to show improvement in patient's cardiovascular system as the final data point shows:

    "The incidence of major cardiovascular events were lower in the EPA group than in the ezetimibe group (9.5% vs. 36.4%, p=0.03 by log-rank test)."

    It seems that LDL-C is not the end all be all answer for those in need of cardiovascular therapy.

    Disclosure: I am long AMRN.

    Sep 15 4:30 PM | Link | 2 Comments
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