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March 27, 2014

No Basis for Serelaxin Approval, Public Citizen Tells FDA Advisory Committee

Drug Failed on All Counts in Pre-Approval Clinical Trial

WASHINGTON, D.C. – The U.S. Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee should vote to reject the approval of serelaxin, a new medication intended to treat patients with acute heart failure, because the single study conducted to support approval demonstrated that the treatment was not effective in easing patients’ initial symptoms, Public Citizen said in a testimony today.

One million Americans are hospitalized every year for acute heart failure, one of the most common causes of hospital admissions in Americans 65 years of age and older. Serelaxin was developed to improve these patients’ symptoms during the first few days after admission to the hospital.

However, the treatment failed to show any meaningful benefit on the symptoms or progression of acute heart failure, despite the company’s best efforts to cast the data in a favorable light. The FDA’s clinical reviewer consequently recommended against approval of serelaxin, as did a key committee of the European Medicines Agency last January. However, in June 2013, the FDA prematurely labeled serelaxin a “Breakthrough Therapy” due to preliminary findings from the pivotal trial.

“The findings from the single trial conducted to support approval show that serelaxin not only is not a breakthrough medication, but it failed to meet even the modest goals – to improve patients’ symptoms – set out at the beginning of the study,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “The advisory committee and the FDA should follow the advice of the FDA’s clinical reviewer and reject the drug, at least until data from an ongoing, larger trial are made available.”

See Public Citizen’s testimony.

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