FDA calls for more data on Merck combo drug; Good results with allergy drug

The US Food and Drug Administration (FDA) has issued a Complete Response Letter to drug giant Merck & Co (NYSE: MRK) regarding its New Drug Application for MK-0653C, the combination of cholesterol lowerers Zetia (ezetimibe) and atorvastatin (Lipitor from Pfizer, which has now gone off patent in the USA but is the subject of a law suit between Merck and Pfizer).

In the letter, the FDA advised Merck that it has completed its review of the submission and stated that additional data are needed. Merck plans to discuss next steps with the agency in the near future, including new data that are expected to be available later this year, which may address the FDA's comments, the company said.

If eventually approved, the combination would add to Merck’s statins franchise, which already includes Zetia and Vytorin, a combination of ezetimibe and Zocor (simvastatin, also now well of patent). Vytorin has, however seen dwindling sales due to concerns about its efficacy.