In a 12-1 vote Dec. 15, the agency’s Cardiovascular and Renal Drugs Advisory Committee ruled that new evidence supports use of the heart failure drug sacubitril/valsartan to treat patients in heart failure with preserved ejection fraction. At present, the FDA has not approved any medication for this condition, known as HFpEF, reports Medscape.
On Dec. 16, the committee recommended in an 8-4 vote that existing evidence from a controversial clinical trial supported the use of the blood pressure drug spironolactone to treat HFpEF. The drug already is approved to treat heart failure with reduced ejection fraction, or HFrEF, according to a separate Medscape report.
While the FDA typically follows advisory panel recommendations on regulatory drug decisions, it is not obligated to.
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