FDA Delays Decision On Vytorin
By Dee Chisamera
09:36, January 26th 2008
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FDA Delays Decision On Vytorin

The decision on Vytorin has yet to be taken, as health officials continue discussions on the drug’s effectiveness, but a final answer is expected to be given after the final trial results are out. The issue came to the attention of specialists earlier this month, when some trial tests have proven that the medication had no beneficial effect on patients.

Dr. John Jenkins, director of the FDA’s Office of New Drugs, Center for Drug Evaluation and Research, explained in a teleconference: “We have not yet received a final study report and can’t explain why Vytorin didn’t lead to lesser amounts of plaque compared to patients treated with simvastatin alone.”

The latest tests on Vytorin, which a combination of two drugs, Zetia (Ezetimibe), an anti-hyperlipidemic medication meant to decrease cholesterol absorbtion in the intestine, and marketed by Merck and Schering-Plough, and Zocor (Simvastatin), a statin used to control high cholesterol levels and prevent cardiovascular disease, have shown that instead of reducing the plaques of fat in arteries that are responsible for heart problems, they’ve doubled in size.

“Once we receive the final study report, we estimate it will take as long as six months for us to fully evaluate the results of the Enhance study," Dr. Jenkins said. "And we will be considering whether any further action is warranted in regard to Zetia or Vytorin, and also whether this study has any impact on our approach to the approval of lipid-lowering drugs."

Millions of people are taking cholesterol lowering drugs in order to prevent cardiovascular complications. The decision has been delayed so far, but FDA promised it will make one as soon as possible.  Both Zetia and Vytorin significantly increased the incomes of the two companies, Merck and Shering-Plough, and so the decision will be of most importance to them and the patients who have been recommended Vytorin.



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