Amarin's Vascepa Momentum Builds Ahead Of Next Week's FDA AdComm
Sales of the triglyceride-lowering medicine soared to $112.4m in the third quarter even before a label expansion that depends on the outcome of a vital US FDA advisory committee meeting on 14 November.
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Promotional efforts will include distinguishing icosapent ethyl from fenofibrates, niacin and omega-3 mixtures, which have failed to demonstrate CV risk reduction in clinical studies. Company execs highlight flexibility provided by the US FDA in expanded labeling and dismiss concerns over absence of CV death risk reduction from indication statement.
Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.
Philadelphia is due to host the American Heart Association (AHA) meeting for the first time from 16-18 November, with the conference taking place in its condensed three-day format for just the second time. Scrip takes a look at the expected highlights.