FDA committee fails to back Vytorin in new indication

A US Food and Drugs Administration advisory committee has failed to back Merck & Co’s (NYSE: MRK) cholesterol drug Vytorin (ezetimibe/simvastatin) for use in a new indication.

The advisory panel voted 10-5 against allowing Merck to claim that Vytorin reduces the risk of heart attacks and strokes in patients with coronary heart disease.

The company had submitted data from an 18,000-patient trial known as IMPROVE-IT, which showed that a combination treatment known as Vytorin, comprising Zetia and an older cholesterol-lowering drug, simvastatin, reduced the rates of heart attack, stroke and death by 6.4% compared with simvastatin alone.