Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Serelaxin
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Public Citizen strongly opposes the approval of serelaxin for acute heart failure because it has exceedingly marginal, if any, benefits on subjective, transient, shortness of breath symptoms and no proven benefits on any objective cardiovascular outcomes. The FDA should follow the lead of a key committee of the European Medicines Agency and the recommendation of its own clinical reviewer in rejecting the drug unless it ultimately demonstrates a clinically meaningful benefit in a larger, ongoing trial.