Pargluva won’t launch within next two years, Bristol-Myers Squibb says

Share this article:
Bristol-Myers Squibb said its diabetes drug Pargluva (muraglitazar) won't be launched in 2006 or 2007, The Wall Street Journal reported today.
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.
Share this article:

Email Newsletters

More in News

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.

HHS shows how diabetes adds up

HHS shows how diabetes adds up

A 2005-to-2010 survey shows diabetics 65-and-up juggle at least four co-morbid conditions and five medications for them.

AstraZeneca beefs up respiratory portfolio

AstraZeneca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.