Irish pharma Amarin wins FDA panel approval for heart drug

drug as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.

Until now, Amarin was approved only for a much smaller niche indication – the lowering of triglycerides in patients who have extremely high levels of the blood fats. Some patients in the trial reported slightly higher risk of bleeding and a small increase in irregular heart rhythm, safety concerns that panel members suggested highlighting on the drug’s label.

In May, the FDA granted Amarin priority review for Vascepa in relation to a much wider group of patients who have less extreme levels of the dangerous blood fats. The company says it is a condition affecting millions of patients.

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