Merck & Co.’s cholesterol drug Vytorin has been shown to prevent heart problems in patients with chronic kidney disease, but health regulators are hesitant to fully approve the drug for that purpose. According to Reuters, the U.S. Food and Drug Administration agreed to change the prescribing label for Vytorin to reflect the drug’s effects on heart disease, but declined to allow Merck to market Vytorin as an approved treatment.
“The final outcome is slightly disappointing, as many street observers had expected an actual new indication claim,” said ISI Group analyst Mark Schoenebaum.
Merck said it ran a randomized study on Vytorin, which proved the statin lowered the risk of heart problems in patients with chronic kidney disease. The FDA denied the company an indication claim, however, because the company’s controlled study of Vytorin failed to identify the individual contributions of Zetia and Zocor, two other prescription drugs.
The decision came Wednesday after Merck submitted a request for the indication. Vytorin has already been approved for lowering cholesterol, but the company was hoping to expand its use in strokes and other heart problems, Reuters said.
Chronic kidney disease affects roughly 14 percent of the people in the United States, the news agency reported. The condition has been shown to put people at a higher risk for developing heart disease.
