Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review
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.
You may also be interested in...
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.
The court included its decision on Amarin’s ’s petition for a writ of certiorari among the single-line denials of nearly 200 appeals to consider decisions in civil litigation and convictions in criminal cases. However, Amarin still eyes curbing competition from omega-3 supplements.
Novartis and Roche will present alongside up-and-coming biotechs and microcaps.