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 Throws More Cold Water On Amarin’s Hopes For Vascepa 1

Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned the foundation of the application, leaving little doubt as to the ultimate fate of the proposed new indication. As veteran biotechnology reporter Adam Feuerstein tweeted:

“The chance of FDA approval for Anchor went from 0.00000001% to 0.00000000001%.”

Click here to read the full post on Forbes.

 

And The Fat Lady Sings

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.