Public Citizen asks FDA to hold off on Pargluva approval
"We question why a drug that an FDA medical officer has concluded causes dose-related edema, weight gain and congestive heart failure needs to be approved for diabetic patients who are already at increased risk for cardiovascular adverse effects and who already have multiple drugs available to treat their conditions," the consumer group wrote in a letter sent to the FDA last week.
The fate of the drug remains unclear.
In October, the FDA issued Bristol-Myers Squibb and Merck an approvable letter asking for more heart safety information before the FDA made a final decision. Company officials said it might take up to five years to compile the data.
Yesterday a Wall Street Journal report said that Bristol-Myers Squibb won't launch Pargluva until after 2007.
The newspaper report also said the company 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 with some analysts predicting sales of more than $1 billion annually.