Irish drug company Amarin has applied to US regulators for approval to sell its purified omega-3 fish oil as a treatment for people with very high blood fats.
The company said yesterday it had made the new drug application to the Food and Drug Administration. It estimates that in the United States alone, there is a target market for its drug of four million people.
AMR-101 has successfully completed a series of safety and efficacy trials, producing figures that, if anything, were better than expected.
Triglycerides are a type of fat stored from food intake and released as energy. At elevated levels, they are seen as increasing the risk of heart disease. The application relates to patients with “very high” levels of triglycerides.
The company has also produced clinical trial data showing efficacy in targeting a larger market of people with “high” triglycerides but that is not part of the current FDA application.