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 Approves Vascepa, A New Fish Oil Pill From Amarin 1

The FDA has approved a new prescription formulation of fish oils for the treatment of very high levels of triglycerides. The news was  first reported by The Street reporter Adam Feuerstein.

The drug will be sold under the brand name Vascepa. According to the company, it will be indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG > 500mg/dL).

Vascepa contains ultra-purified ethyl EPA, an omega-3 fatty acid. Vascepa will be the second prescription fish oil formulation, following GlaxoSmithKline’s Lovaza, which Feuerstein said generates about $1 billion in annual sales.

The triglyceride-lowering efficacy of Vascepa has been studied in two 12-week, placebo-controlled phase 3 studies: ANCHOR, in patients with triglyceride levels between 200 and 500 mg/dl, and MARINE, in patients with triglyceride levels between 500 and 2000 mg/dl. Last year Amarin announced the commencement of REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial), a trial designed to evaluate the efficacy of Vascepa when given in addition to  a statin in reducing major cardiovascular events in a high-risk population.

A recent meta-analysis of studies with various preparations of fish oils found no evidence of a reduction in cardiovascular events with fish oil supplements in patients with a history of cardiovascular disease.

Click here to read the press release from Amarin.

Click here to read prescribing information for Vascepa.