U.S. FDA panel votes against expanded use of Amarin drug

Wed Oct 16, 2013 5:27pm EDT

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(Reuters) - Amarin Corporation Plc's triglyceride-lowering drug Vascepa should not be approved for use in a broader patient population until results from an additional study have been analyzed, an advisory panel to the U.S. Food and Drug Administration said on Wednesday.

The panel voted 9-2 against approval of the drug for patients who also take a cholesterol-lowering statin such as Pfizer Inc's Lipitor and are at high risk of coronary heart disease.

While the drug reduced triglycerides, or blood fats, in a clinical trial, the panel was not convinced that lowering triglycerides would automatically lead to a reduced risk of coronary heart disease or death.

The FDA is not bound to follow the recommendations of its advisory panels but typically does so.

Vascepa is already approved to reduce triglycerides in patients who are not taking statins. Amarin had hoped to market the drug to a much broader patient population. But Dr. David Cooke, clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine and a panelist, said it "has not yet been proven" that Vascepa, or any medication that lowers blood fats, except statins, decreases cardiovascular risk.

The FDA suggested that approval should be withheld pending the results of an 8,000-patient trial being conducted by Amarin that is expected to shed light on whether Vascepa actually cuts cardiovascular risk. Results of the trial are expected in late 2016.

Raghuram Selvaraju, an analyst at Aegis Capital Corp, said the company will "in all likelihood need to raise additional capital" in order to fund operations through to the release of those results. While those results "could still vindicate Amarin," he said, "we believe that moving to the sidelines is probably the most appropriate strategy at this juncture."

Selvaraju cut his recommendation on the stock to "hold" from "buy."

Amarin's shares were halted on Wednesday pending the FDA panel's discussion. They fell to a year-low of $4.50 on Monday following publication of the FDA's initial review of the company's application, which was more cautious than investors had expected.

Vascepa is a purified ethyl ester of eicosapentaenoic acid (EPA) derived from fish oil. EPA, along with a-linolenic acid and docosahexaenoic acid (DHA) are collectively referred to as omega-3 fatty acids.

EPA and DHA are also the major constituents of fish oils derived from cold water fish. The only other approved fish-oil treatment for severe hypertriglyceridemia is Lovaza, which is made by GlaxoSmithKline Plc. Lovaza has not been shown to cut the rate of heart attack or stroke.

(Reporting by Toni Clarke in Washington; Editing by Bernard Orr)

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Comments (1)
AZ_Dine wrote:
FDA Continues Government Sponsored Genocide of Minorities

On October 16th the Federal Drug Administration dealt a fatal blow to the life expectancy of minorities in the United States. By a vote of 9-2 they rejected a drug, proven safe and effective, that would allow the preventive treatment of Type 2 Diabetes in its early stages, a condition that affects minorities at a higher percentage rate than whites and is climbing at 1.9 million cases annually. Those who pass from pre-diabetic conditions to Type 2 Diabetes are twice as likely to die as those who do not.

The drug that was disallowed is called Vascepa, a prescription form of purified fish oil that lowers blood fat to levels that the body can process and along with diet and exercise improves the lives of patients without having to pass through to full blown type 2 diabetes for treatment first.

Who is most inclined to T2D? The following statistics are from the U.S. Department of Health and Human Services who were not consulted in the FDA decision:

• 14.2% of native Americans (the Navajo being one of the highest in this group—33.5% are diagnosed with T2D)
• 12.6% of Black Americans
• 11.8% of American Hispanics and Latinos
• 8.4% of American Asians
• 5.5% of Alaskan native Americans

For the Native American population the FDA action is not too dissimilar to that of the government dispensing blankets infected with small pox in the 19th century, but with considerably worse consequences.

It costs well over $175 billion annually to treat T2D, a figure that is not likely to change under Obamacare though access to safe and effective drugs would—but only if the FDA allows them. Seems they won’t, preferring instead to endanger the lives of minorities by focusing on non-preventive therapies that may be less effective but far more profitable to the FDA and large pharmaceutical companies.

Oct 22, 2013 10:00am EDT  --  Report as abuse
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