FDA evaluation of Vytorin study not due until mid-2008

WASHINGTON The Food and Drug Administration has stated that it will take up to six months to evaluate trial data on the ENHANCE study before deciding if it will take regulatory action on Merck and Schering-Plough’s cholesterol drug Vytorin, after it receives the final study report from the companies.

The ENHANCE trial has been the subject of a congressional inquiry that has expanded to include direct-to-consumer advertisements, Medicare payments, company executives’ stock transactions and the relationships between drug companies and nonprofits.

After considering all the information, the FDA will then determine if any regulatory action is warranted for Zetia, a drug used in Vytorin’s formulation or Vytorin itself. In addition, the agency may consider revising its approval process for drugs that lower LDL cholesterol.

The FDA said it does not see any reason to change Vytorin’s labeling based on the ENHANCE study so far but told physicians and patients to consider all information when making prescription choices.