Merck Cholesterol-Lowering Drug Good for Kidney Patients, FDA Staff Says
Merck’s cholesterol-lowering drug Vytorin was effective in reducing the rate of heart attacks or other cardiovascular problems in patients with kidney disease, U.S. Food and Drug Administration reviewers said, according to Reuters.
The FDA reviewers also said Vytorin, which pairs a new type of cholesterol fighter Zetia with Merck's older statin drug Zocor, is unlikely to cause or promote cancer, according to Reuters.
"Risk of cancer did not increase consistently over time with longer use of ezetimibe/simvastatin, as would be expected if a drug caused cancer or promoted the growth of pre-existing cancers," FDA researchers wrote in documents ahead of an advisory panel that will look at Zetia and Vytorin on November 2, according to Reuters.
The FDA review could help ease fears about the drug after a 2008 clinical trial showed substantially more cancer cases among patients taking Vytorin than those taking a placebo.
"In our opinion, FDA's review of SHARP strongly supports Zetia's safety," Leerink Swann analyst Seamus Fernandez wrote in a note, according to Reuters.
"Most importantly, the FDA reviewer comments and safety review suggest no new safety concerns and that Vytorin/Zetia is not associated with risk of either incident cancer or cancer deaths. We believe these data should help lay to rest investor concerns about Vytorin/Zetia's safety."
Both Vytorin and Zetia are already approved as cholesterol-lowering drugs, but Merck is now hoping to expand the indications to include treating heart problems in patients with chronic kidney disease. If approved, the drug would be the first treatment with that specific indication.