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news.The development of Pargluva, a diabetes drug from Bristol-Myers Squibb and Merck & Co, is set to be delayed after the FDA requested additional safety information relating to the treatment.
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According to Bristol-Myers and Merck, the FDA wishes to address more fully the cardiovascular safety profile of the drug. The agency will therefore need data from ongoing trials, or those completed since the safety data from the last formal regulatory submission.
The decision may come as a shock for the companies after an FDA advisory committee last month recommended the drug for approval, judging that the cardiovascular risks were manageable and that the benefits outweighed the risks.
The partnership had expected the drug to become the first FDA-approved product in the class known as dual peroxisome proliferators-activator receptor agonists.
Analysts, however, have already suggested that the regulatory decision could see the launch of the drug delayed by about a year. The companies, meanwhile, insist that they are eager to begin discussions with the FDA to address this issue and to determine what additional information may be necessary.
Bristol-Myers Squibb and Merck are collaborators in the global development and commercialization of Pargluva. The new drug application for Pargluva was submitted to the FDA in late December 2004.