There's more bad news--or analysis--for Merck's drug development efforts. After the FDA turned down Cordaptive, Merck's new cholesterol medication, there was much head scratching over why. The drug giant never explained the reasons for the rejection. Now Pharmalot is highlighting a note from a Credit Suisse analyst who believes that the combination of niacin and the chemical component laropiprant--to prevent flushing--may have been doomed by cardiovascular signals emitted by the chemical.
The numbers of patients who demonstrated these signals may have been small, but Merck researchers couldn't explain just why they had them. With plenty of me-too alternatives on the market and an uncertain risk profile, the agency had little reason to provide an approval.
The kicker, for Merck, is that the analyst doesn't see any definitive new data on laropiprant coming from an ongoing study, leaving the drug giant to mount new trials if it wants to make its case to the FDA. And that could delay any approval for years.
- read the report from Pharmalot
ALSO: The axeman cometh to Merck's sales force. The drugmaker plans to lop off about 15 percent in the sales ranks, or 1,200 jobs. Layoff report
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