Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech Reply

A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use of the drug beyond its current highly restricted FDA-approved indication (see reports in Forbes, the New York Times, and the Wall Street Journal.)

Click here to read the full post on Forbes.

 

 

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Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill Reply

After nearly a year of uncertainty, Amarin  announced  its commitment to complete REDUCE-IT  (Reduction of Cardiovascular Events with EPA – Intervention Trial). The trial is designed to test the effects on cardiovascular outcomes of Vascepa, the company’s high EPA omega-3 prescription fish oil product, in people with moderately elevated triglyceride levels between 200-499 mg/dL.

Last year the company said it might discontinue support of the trial, which began in 2011, after the FDA turned down the company’s application for an expanded indication for Vascepa.

Click here to read the full post on Forbes.

 

FDA Approves New Omega-3 Supplement Reply

The FDA has approved a new omega-3 supplement for the treatment of adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher. The drug, which will be marketed under the brand name of Epanova, is manufactured by AstraZeneca, which acquired the drug when it purchased Omthera Pharmaceuticals in 2013.

Click here to read the full post on Forbes.

 

 

 

FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial Reply

An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dl). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20% of the US population who have elevated triglycerides (>200 mg/dl) and existing CV disease or who are at high risk for CV disease.

Click here to read the full story on Forbes.

 

 

 

 

Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa Reply

On Wednesday an FDA advisory  panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions with elevated triglycerides (>200 mg/dl) and existing CV disease or at high risk for CV disease. The NDA for this indication is based on the ANCHOR trial, which showed that Vascepa lowered triglycerides in the target patient population.

The FDA review (available here) raises 2 troubling issues. The first is fairly simple and relates to the performance of the placebo in ANCHOR.  In its briefing documents the FDA raises the disturbing and unusual possibility that the mineral oil placebo used in the trial may not have been biologically inert. LDL levels in the placebo group went up 9% in the placebo group and this will make it difficult to assess the true effect of Vascepa. It’s unlikely that this issue by itself will entirely derail the NDA, but it may well serve to undermine confidence in the trial and put the panel in a critical frame of mind.

More significant, to my mind, is the lack of any evidence for any important improvement in clinical outcomes that can be tied to Vascepa….

Click here to read the full post on Forbes.

Link To Prostate Cancer Brings More Bad News For Fish Oil Story Reply

Adding more confusion to an already fishy story, a new study has found a significant association between omega-3 fatty acids and the risk of prostate cancer. Although the linkage had been previously observed, the finding surprised the investigators, who wrote that “these findings contradict the expectation that high consumption of long-chain omega-3 fatty acids and low consumption of omega-6 fatty acids would reduce the risk of prostate cancer.”

In a report published in JNCI, investigators analyzed data from men who had participated in the SELECT (Selenium and Vitamin E Cancer Prevention Trial) trial. They compared 834 men who developed prostate cancer with 1,393 matched controls. When compared with men who had the lowest levels of omega-3 fatty acids, men in the highest quartile of omega-3 fatty acids were at significantly increased risk for low-grade, high-grade, and total prostate cancer:

Click here to read the full story on Forbes.

 

Daily Fish

Another Disappointing Study For Fish Oil Supplements 3

Another large study has failed to find any benefits  for  fish oil supplements. The Italian Risk and Prevention Study, published in the New England Journal of Medicine, enrolled 12,513 people who had not had a myocardial infarction but had evidence of atherosclerosis or had multiple cardiovascular risk factors. The patients were randomized to either a fish oil supplement (1 gram daily of n-3 fatty acids) or placebo.

After 5 years of followup, the primary endpoint– the time to death from cardiovascular causes or admission to the hospital for cardiovascular causes– had occurred in 11.7% of the fish oil group versus 11.9% of the placebo group (adjusted hazard ratio 0.97, CI 0.88-1.08, p=0.58). There were no significant differences in any of the prespecified secondary endpoints.

Click here to read the full post on Forbes, including comments from James Stein and Dariush Mozaffarian

A typical softgel