A Food and Drug Administration advisory panel have ruled 10 to 5 against allowing Merck claim their drug Vytorin (ezetimibe, simvastatin tablets) reduces the risk of heart attacks and strokes in patients with acute coronary syndromes.
Vytorin is currently approved as an adjunct to diet in primary hyperlipidemia (heterozygous familial and non-familial) or mixed hyperlipidemia: to reduce elevated total-C, LDL-C, apo B, TG and non-HDL-C, and to increase HDL-C and as an adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia (HoFH) are not available: to reduce elevated total-C and LDL-C.
Results from Improve-It study, which included 18,000 patients, concluded that Vytorin did in fact reduce heart attack and stroke risk by 6.4% compared to simvastatin alone, though the FDA panelists said they were not convinced the benefit was clinically meaningful.
The FDA does not have to follow the advice of its advisory panel but it generally does so.
“Today’s discussion is one step in the regulatory process,” Dr. Daniel Bloomfield, vice president of cardiovascular disease at Merck Research Laboratories, said in a statement. He said the company would continue to work with the FDA to achieve their desired indications for Vytorin as a treatment to reduce the risks of heart attacks and strokes.
For more information visit Merck.com.