Last week, Bristol-Myers Squibb decided to halt development of its promising new diabetes drug, PargluvaTM (muraglitazar).
You may recall the news last September when an FDA advisory panel recommended the drug for approval. You may also recall an article in the Journal of the American Medical Association (JAMA) a month later that warned of Pargluva's link to increased risk for heart attack and stroke.
If approved, Pargluva would have become the first marketed drug in a relatively new class of compounds called glitazars. These drugs not only lower glucose, but can improve cholesterol levels. Both of these benefits were documented in a study appearing in this month's Diabetes Care which pitted Pargluva against a similar drug, Actos (pioglitazone).
In light of possible health risks associated with Pargluva, the FDA last year requested more information on the drug's cardiovascular safety profile. Bristol-Myers Squibb decided that the time required to run additional safety trials, up to 5 years, would not be worth the effort - given the diabetes drugs projected to become available in the coming years.
For Bristol-Myers press release:
Bristol-Myers Squibb Announces Discontinuation Of Development Of Muraglitazar, An Investigational Oral Treatment For Type 2 Diabetes
For the Diabetes Care, May 2006 study (abstract only):
Improvement of Glycemic Control, Triglycerides, and HDL Cholesterol Levels With Muraglitazar, a Dual (/) Peroxisome Proliferator–Activated Receptor Activator, in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
For our September 2005 post:
New Diabetes Drug Gets FDA Panel Backing
For our October 2005 post:
PargluvaTM on Hold
Some news summaries:
New Drug Helps with Diabetes Control (Reuters)
Bristol Drops Diabetes Drug (New York Times)