Health & Medicine
U.S FDA Votes Against Expanded Use of Fish Oil Drug
Kathleen Lees
First Posted: Oct 17, 2013 01:26 PM EDT
Many studies suggest the benefits of fish oil, showing that it can decrease the risk of type 2 Diabetes as well as coronary heart disease.
Yet a fish oil drug has just been voted against by the U.S. Food and Drug Administration (FDA) for expanded use to treat patients with heart diseases as part of any included regiment for their medications. Health officials note that more studies need to be included before it can be used.
Dublin-based Amarin has asked the FDA to allow marketing of Vascepa, a product that was approved by the FDA in July 2012 and was used by people with a very high presence of triglycerides.
As the drug has been shown to lower cholesterol via blood levels, advisory panels voted 9-2 against the product for patients that also take cholesterol-lowering statins that can help prevent coronary issues.
As the FDA is not obligated to take steps in accordance with advisory panels, they decided to so in this case.
According to clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine and a panelist, Amarin's aim to market a larger target population "has not been proven," and other medications, including Vascepa, have not been confirmed to decrease cardiovascular risks at this time, except for statins.
Officials are currently waiting on the clinical trial results for Vascepa. The trial, which involves 8,000 patients, will not be released till late 2016.
According to Yahoo News, Jeffries analyst Thomas Wei was shocked by the decision, in which he expected members to vote 7-3 in favor of expansion. As of Thursday morning, Wei said he believes that the delay for the study of the drug's debut could be pushed back as far as 2019.
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First Posted: Oct 17, 2013 01:26 PM EDT
Many studies suggest the benefits of fish oil, showing that it can decrease the risk of type 2 Diabetes as well as coronary heart disease.
Yet a fish oil drug has just been voted against by the U.S. Food and Drug Administration (FDA) for expanded use to treat patients with heart diseases as part of any included regiment for their medications. Health officials note that more studies need to be included before it can be used.
Dublin-based Amarin has asked the FDA to allow marketing of Vascepa, a product that was approved by the FDA in July 2012 and was used by people with a very high presence of triglycerides.
As the drug has been shown to lower cholesterol via blood levels, advisory panels voted 9-2 against the product for patients that also take cholesterol-lowering statins that can help prevent coronary issues.
As the FDA is not obligated to take steps in accordance with advisory panels, they decided to so in this case.
According to clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine and a panelist, Amarin's aim to market a larger target population "has not been proven," and other medications, including Vascepa, have not been confirmed to decrease cardiovascular risks at this time, except for statins.
Officials are currently waiting on the clinical trial results for Vascepa. The trial, which involves 8,000 patients, will not be released till late 2016.
According to Yahoo News, Jeffries analyst Thomas Wei was shocked by the decision, in which he expected members to vote 7-3 in favor of expansion. As of Thursday morning, Wei said he believes that the delay for the study of the drug's debut could be pushed back as far as 2019.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone