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FDA accepts marketing application of Amarin’s heart pill
Nov 26, 11 FDA ApprovalsBiopharmaceutical company Amarin Corp said U.S. health regulators have accepted the marketing application for its heart pill AMR101 and set an eight-month review period.
MKM Partners analyst Jon LeCroy said the decision was on expected lines, and the next catalyst for the company will be the data from a 40-week trial, in December.
The pill gives the Nasdaq-listed Irish company ammunition to take on GlaxoSmithKline Plc’s popular heart pill Lovaza.
Both drugs contain omega-3 fatty acids, the heart-protecting chemicals found in fish oil, and are designed to treat patients with very high levels of triglycerides, a blood fat that contributes to heart disease alongside cholesterol.
Amarin, which submitted its new drug application on September 26, is also testing its drug in a wider patient population with high triglyceride levels who are also receiving Statins.
Separately, the company said one of its directors, David Feigal, resigned citing other commitments.
Shares of the company, valued at about $903.8 million, were up 6.6 percent at $7.11 during the day. Earlier, they touched a high of $7.31 on Friday on Nasdaq.
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(Reuters)
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