Panel rejects Merck over-the-counter statin bid

By Lisa Richwine

SILVER SPRING, Maryland (Reuters) - A U.S. advisory panel urged the government on Thursday to reject Merck & Co Inc's latest bid to sell the first cholesterol-lowering drug without a prescription.

The committee voted 10-2, with one abstention, against recommending over-the-counter sales of Merck's cholesterol fighter Mevacor. Most of the experts said a company study failed to show patients could decide for themselves if they were appropriate candidates for the medicine.

"Of the patients who chose the drug, frequently it wasn't right for them," said Dr. William Shrank, a panel member and internal medicine expert at Harvard Medical School.

The Food and Drug Administration will make the final decision but usually follows panel recommendations. Merck said an FDA ruling is expected in the first quarter of 2008.

Mevacor is one of the statin drugs taken by millions to cut cholesterol and the risk of heart disease, the leading killer of Americans. Other prescription statins include Merck's Zocor and Pfizer Inc's Lipitor.

Merck is making its third bid for approval of a low-dose, non-prescription version of Mevacor.

The company argued before the panel that an estimated 20 million Americans with moderate heart-disease risk could benefit from a statin, but just 6 million of them are on treatment.

Having Mevacor available on drugstore shelves could lure many untreated patients to therapy, said Edwin Hemwall, an official with Merck Research Laboratories.

"Over time it will reduce the risk of a first heart attack and provide a real impact on public health," Hemwall said.

GlaxoSmithKline Plc recently acquired exclusive U.S. rights to sell over-the-counter Mevacor in return for undisclosed milestone and royalty payments to Merck.