Pargluva won’t launch within next two years, Bristol-Myers Squibb says
In the newspaper report, the company said it still has not decided whether it will pursue marketing approval for Pargluva and likely won't make a decision before next year.
Pargluva is the first drug in what had been considered a promising new class of drugs for millions of diabetics.
In October, researchers released data indicating that use of the drug more than doubles the risk of life-threatening cardiovascular complications.
The Cleveland Clinic researchers, who also pointed out the heart risks of Vioxx in 2001, said the agency should not approve the drug until additional research is conducted.
Also in October, the FDA issued an approvable letter, indicating the drug could be cleared for marketing once additional information to be provided by BMS is received and reviewed.
Bristol-Myers Squibb said it could take five years to obtain this additional data and that the company was considering a range of options, including additional studies or terminating further development. "We're still convinced that this is an important product," Lamberto Andreotti, president of the company's worldwide pharmaceuticals division, told The Journal adding that the company remains in discussions with the FDA over Pargluva.