US backs wider use of fish oil to prevent heart attack

Vascepa cuts risk by 25 pct

WASHINGTON, Nov 17, (Agencies): Government health experts on Thursday recommended broader use of a prescription-strength fish oil drug to help many more patients at risk for heart attack, stroke and related health problems.

Currently the drug, Vascepa, is approved for a relatively narrow group of patients with extremely high levels of triglycerides, a type of fat in the blood linked to heart disease.

Irish drugmaker Amarin is seeking approval for a much larger group of patients who have lower fat levels but are still at risk of heart problems, despite taking cholesterol-lowering statin drugs like Lipitor and Zocor.

The panel of advisers to the Food and Drug Administration unanimously supported the expansion based on recent study results showing the drug can cut rates of life-threatening heart problems in high-risk patients.

“There is no doubt this drug could benefit a substantial portion of the US population and meet an unmet need,” said Dr. Jack Yanovski, a panelist and hormone specialist from the federal National Institutes of Health.

The FDA is not required to follow the group’s advice and is expected to make its decision by the end of the year.

Financial analysts predict that broader use could translate into billions in sales for Amarin. Vascepa costs around $300 a month.

Some panelists urged the FDA to tailor the drug’s label to patients who are most likely to benefit.

Decision

“I do not want to see this become what I call cardio candy,” said Philip Posner, a patient representative on the panel.

FDA-written drug labels guide physician prescribing and often determine which uses are paid for by insurers.

Panelists based their decision on a company-funded study showing that Vascepa cut the risk of heart attack, clogged arteries and other cardiovascular problems by about 25%, compared with a dummy treatment. Patients in the study were randomly assigned to take Vascepa or mineral oil capsules as a comparison.

Patients in the trial had high triglycerides and other risk factors for heart problems, such as diabetes.

The results, published last year, came as a surprise because a string of past studies of fish oil failed to show a positive impact on heart health.

The panel noted several potential side effects of the drug, including irregular heartbeats and internal bleeding. But they agreed the drug’s benefits outweighed those risks, which could be monitored and managed by physicians.

Millions of Americans take over-the-counter fish oil supplements for their presumed health benefits. These oils, also called omega-3 fatty acids, are known to reduce triglycerides. But several pharmaceutical trials have tried and failed to show that lowering those fats translates into meaningful benefits for patients.

If approved, Vascepa would be the first fat-lowering drug endorsed by the FDA to reduce heart problems.

Amarin has long tried to differentiate its drug from non-prescription fish oil supplements. Company advertising states that it can take 10 to 40 over-the-counter capsules to equal the daily dose of Vascepa. The drug is taken in four 1-gram capsules per day.

Wall Street analysts have high expectations for broader use of the drug, with some projecting annual sales of $3 billion or higher.

That compares to total company sales of just $228.4 million in 2018, according to Amarin’s financial reports. Vascepa, first approved in 2012, is Amarin’s only product on the US market.

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Patients at high risk for heart disease who cannot afford newer cholesterol-lowering medications are more likely to have heart attacks, strokes and other cardiovascular events within just one year compared to counterparts who were able to get the drugs, a new study suggests.

Clinical trials have shown that the new drugs, called PCSK9 inhibitors, can lower LDL-cholesterol significantly and also improve cardiovascular outcomes in people who don’t get enough benefit from statin drugs, which are the first-line treatment for high cholesterol.

The problem with the newer drugs is the cost. During the period covered by the new study, the cost of the PCSK9 inhibitors in the US was in the range of $14,000 per year, according to the American Heart Association, which last fall encouraged drug companies to lower their prices to improve patient access. Even when patients have insurance, the out-of-pocket costs for these drugs can be prohibitive, earlier studies have shown.

“One of the most surprising things we saw in this study was a difference in risk in as little as 11.5 months of therapy,” said study coauthor Kelly Myers. “That means there is a beneficial effect in less than a year.”

Myers is chief technology officer at the FH Foundation, a non-profit research and advocacy organization focused on familial hypercholesterolemia, a genetic disease that causes high cholesterol levels.

To take a cvloser look at the impact of patients’ ability to get the new drugs, the researchers combed through healthcare claims data on 139,036 adults with hypercholesterolemia who were prescribed a PCSK9 inhibitor between August 2015 and December 2017.

When they analyzed the data, the researchers found that 88,770 patients (63.8%) had a history of atherosclerosis and 2,899 (2.1%) had a documented diagnosis of familial hypercholesterolemia. Insurers had rejected nearly twothirds (61%) of the prescriptions, while 15% of patients had opted not to fill their prescriptions, presumably because of the outof-pocket costs, the researchers said.