FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study

Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.

FDA has taken the rare step of formally rescinding Amarin Corp. PLC’s special protocol assessment for the company’s ANCHOR study of its cholesterol-lowering fish oil drug Vascepa (icosapent ethyl).

Amarin is attempting to expand the indication for Vascepa based on the Phase III ANCHOR study, which showed a reduction...

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