Merck ($MRK) is one step closer to a new indication for its blockbuster cholesterol-fighter Vytorin. In advance of an FDA advisory committee meeting Wednesday, agency reviewers released their assessment of a new study of the drug in kidney patients--and it was a qualified thumbs up. Vytorin cuts the risk of heart attacks and other cardiovascular problems 16% compared with a placebo, the FDA staffers said.
The 9,000-patient SHARP study didn't show an identical benefit across the board, however. As the review states, Vytorin appeared to offer more help to kidney-disease patients who aren't on dialysis. "The treatment effect appears to be heterogeneous among patients with different renal function status," the agency staff concluded (as quoted by Bloomberg).
Vytorin is a combination drug comprised of Merck's statin Zocor and its cholesterol-absorption blocker Zetia. The drug has had a patchy history, datawise; a much anticipated study comparing Vytorin with stand-alone Zocor therapy found the combination pill didn't treat artery-narrowing any better than Zocor alone. Still, the drug delivered $2 billion in 2010 sales, while Zetia brought in $2.3 billion.
The new study also combats another bad patch in Vytorin's data history. A 2008 trial showed more cancer patients among Vytorin patients than placebo patients, but SHARP didn't show an increasing risk of cancer with longer use of the drug, "as would be expected if a drug caused cancer or promoted the growth of pre-existing cancers," the FDA said.
Merck is seeking permission to market Vytorin as a treatment for heart problems in patients with chronic kidney disease. It would be the first treatment with that indication, Reuters points out.