The FDA approved a label change that recognizes how Vytorin can prevent heart problems among chronic kidney disease patients, but
didn't specifically give it an approval for that indication. Now Merck ($MRK) is left with a label that opens the door to discussing the use of its drug with doctors, but can't actually market it for that purpose.
The news left analysts feeling a bit deflated. "The final outcome is slightly disappointing, as many street observers had expected an actual new indication claim," noted ISI's Mark Schoenebaum, according to a report in Reuters.
Vytorin, a combination of the cholesterol drug Zetia and the mainstay statin drug Zocor, is prescribed for cholesterol already. But with 14% of the American population diagnosed with chronic kidney disease, Merck was clearly looking for a new approval to boost its product revenue.
Merck researchers may be inspired to do some soul-searching on their study design for the new data supplied to regulators. According to the pharma company's release, the trial "was not designed to assess the independent contributions of each drug to the observed effect," causing the FDA to hold back its OK for the indication.
- here's the release
- get more from Reuters