Developers of diabetes drug say they may not develop it further after safety concerns raised
Friday, October 28th 2005, 11:18 am
By: News On 6
WASHINGTON (AP) _ Developers of a drug to help diabetics control blood sugar levels as well as cholesterol said Friday they are unsure whether they will continue to pursue the treatment after the Food and Drug Adminstration sought additional safety data about it.
Bristol-Myers Squibb, which developed the drug along with Merck, said the studies required to obtain that data could take up to five years to perform. The drug, muraglitazar, would be marketed under the name Pargluva.
The FDA and some doctors who examined company data from drug trials raised concerns that the treatment could be associated with heart problems.
Bristol-Myers Squibb, based in Princeton, N.J., released a statement saying it ``will continue discussions with the FDA and will consider a range of options including conducting additional studies or terminating further development of muraglitazar.''
Last week, the companies said the FDA had issued them an letter saying the drug was approvable if the companies met certain conditions, but the agency's request for more heart safety data had not been made public until Bristol-Myers Squibb issued its statement Friday.
The drug had appeared headed for the market after members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-1 to recommend FDA approval of the drug to treat Type II diabetes, the most common form of the condition, when used alone. The FDA usually follows the advice of its committees but is not required to do so.
The Journal of the American Medical Association last week published an analysis by heart reserachers that found twice as many deaths and cardiovascular problems in diabetic adults taking the drug Pargluva as those on dummy pills or a competing drug.
About 18 million people in the United States are thought to have diabetes, although many do not know it. Untreated diabetes can lead to blindness, loss of limb function, even death.