The FDA has handed Merck ($MRK) a big setback in its attempt to revive its flagging cholesterol franchise with a combo approach that marries generic atorvastatin with ezetimibe. In a short statement put out this morning, the pharma giant says the FDA wants to see more data on the combo, dubbed MK-0653C, and it holds out hope that ongoing studies might satisfy the agency's demands.
Merck has been counting on marrying the active ingredient in Pfizer's ($PFE) generic-challenged Lipitor--atorvastatin--with an active ingredient in Merck's combo drug Vytorin--ezetimibe, used in Zetia--to produce a more powerful cholesterol pill. While Lipitor's value has been gutted by generics, Vytorin use has shrunk, losing market share to rival treatments considered more effective.
"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 pharma company explains in its release.
Matthew Herper at Forbes notes Merck may be referring to ongoing studies of the combo along with Lipitor and Zetia, which are scheduled to wrap over the next few months.
- here's the Merck press release
- get the AP story
- check out the report from Forbes