FDA Panel Endorses a New Pill for Type 2 Diabetics ; Non-Insulin Treatment is for Condition That is Most Often Seen in Overweight Adults
Posted on: Tuesday, 13 September 2005, 06:00 CDT
A day after recommending the first inhaled form of insulin to treat diabetes, an FDA panel yesterday endorsed a new pill that helps control blood-sugar levels.
The pill also helps control cholesterol in people with the most common form of diabetes.
The drug, muraglitazar, will be marketed under the name Pargluva. It was developed by Bristol-Myers Squibb and Merck & Co. A joint statement from the companies said they would conduct extensive monitoring of people using the drug to ensure it causes no long- term problems.
The non-insulin treatment is designed for people with Type 2 diabetes, the most common form of the condition that occurs most often in overweight adults.
Members of the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-1 to recommend FDA approval of the drug to treat Type 2 diabetes when used alone. It voted 7-2 to endorse its use alongside metformin, another treatment.
However, the panel voted 6-3 against recommending its use in combination with a sulfonylurea, still another drug that prompts the pancreas to release more natural insulin into the bloodstream.
The FDA usually follows the advice of its committees, but it is not required to do so. On Thursday, the panel endorsed the first inhalable insulin for diabetics.
Documents released by the FDA this week raised concerns that muraglitazar may increase the risk to people with heart problems.
In studies, a few more people taking the drug died of heart failure or suffered serious heart problems than those taking placebos or undergoing other treatments. However, it was unclear to the FDA whether that effect was directly related to the drug or the result of another factor.
The advocacy group Public Citizen said in a statement yesterday that the drug was too risky to approve because of this and other issues.
About 18 million Americans are thought to have diabetes, although many do not know it. Untreated diabetes can lead to blindness, loss of limb function, or death.
Source: Richmond Times - Dispatch
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