FDA Approves the First Fish Oil Medication to Reduce Cardiac Risks

On Friday, the regulators of the United States granted approval for the widespread use of a fish oil medication called Vascepa. This new drug can help prevent severe heart issues in patients with high cardiac risks who already take cholesterol-lowering pills.

The fish oil drug was approved many years ago for patients with sky-high triglycerides, which is a form of fat found in our blood. The FDA approved its application in a far larger group of people with high, but less serious, levels of triglyceride who have many risk factors, including diabetes and heart disease.

When tested in patients, Vascepa lowered the risk of possibly fatal problems, such as stroke and heart attack, approximately 25%.

The medication’s manufacturer, Amarin, announced the list price of more than $300 each month. The actual amount that people pay would vary, depending on their insurance policies. Also, the company said that it will also provide financial support.

The Irish firm estimates that the new policy makes this fish oil drug a good option for nearly 15 million patients in the United States.

A high level of triglycerides in the blood would block arteries and increase the risk of developing strokes or heart attacks, suffering from heart disease, requiring an artery-clearing process or bypass, or being hospitalized due to chest pain. All of these effects are quite similar to those in increased blood pressure and high cholesterol.

Amarin financed a 5-year research of more than 8,200 people who were at high risks of cardiac diseases. They already took drugs to control diabetes and reduce the levels of harmful cholesterol.

50% of the patients who were given Vascepa with these drugs reduced the risk of heart issues of up to 25% and the risk of death of up to 20%.

While those people who took Amarin’s medication experienced an irregular heartbeat, the side effect was quite insignificant.

Previous studies that examined other fish oil medications to reduce cardiac risk had failed.

It is estimated that heart disease affects more than 120 million adults in the United States. One out of three deaths is caused by this condition. In addition, it costs approximately $500 billion per year for treatment.

A lot of people take OTC fish oil supplements to enjoy benefits for their heart health. However, the dosages are much lower than the potency of Vascepa.

Over the first 9 months in 2019, Amarin made around $287 million of sales from Vascepa. Experts believe that the recent approval would increase its sales up to more than $3 billion per year.




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