With Vascepa’s New CV Claim, Amarin Targets Patients On Other Triglyceride-Lowering Agents
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.
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Hikma and Dr Reddy’s Laboratories are weighing launches of their generics to Amarin’s Vascepa after the US Court of Appeals for the Federal Circuit upheld a favorable lower court ruling. The originator said it would take its appeal to the next level and continued to raise doubts over supply capacity.
A Federal Circuit panel affirmed a district court decision in favor of two generics makers, but Amarin will seek a hearing from the full 12-member appellate court. Vascepa marketing is unchanged for now.
Amarin – and the industry at large – was stunned in March this year when Hikma and Dr Reddy’s walked away from court with an invalidity ruling against six Vascepa patents in the US. The originator’s CEO gave an impassioned update on the current state of play, including the potential for generics to launch ahead of a Federal Circuit ruling later this year or early in 2021.