Bristol-Myers Squibb previously disclosed that it could take up to five years for the necessary studies to be completed to satisfy the FDA request.
The companies have now reached a “mutually acceptable” termination agreement, with all rights to Pargluva, and a back-up compound, returning to Bristol-Myers Squibb as of December 21, 2005.
Pargluva was originally recommended for approval by an FDA advisory committee, but the regulators eventually chose to go against the recommendation due to its concerns about the cardiovascular safety of the drug.
BMS said in a statement that it is continuing discussions with the FDA and is considering a range of options including conducting additional studies or terminating further development of the drug.