FDA information request to delay Pargluva launch
The FDA has requested additional safety information before it can approve Bristol-Myers Squibb's potential blockbuster diabetes drug Pargluva (muraglitazar).
The request for more information could set back plans of BMS and Merck to market Pargluva for at least a year, according to analysts' estimates.
"The FDA has requested additional safety information from ongoing trials, or those completed since the safety data from the last formal regulatory submission, to address more fully the cardiovascular safety profile of Pargluva," the companies said in a joint statement.
Pargluva represents a new approach to treating Type 2 diabetes, the most common form of the disease. The drug could be the first FDA-approved product in the class known as dual peroxisome proliferators-activator receptor agonists, or PPAR.