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Third new diabetes drug gets panel's OK
Diabetics get third piece of good news in a week, with new treatments moving forward.
September 9, 2005: 3:16 PM EDT

NEW YORK (CNN/Money) - An FDA panel of experts voted Friday in favor of muraglitazar, a once-a-day pill meant to lower blood sugar and reduce the risk of heart disease.

The experts voted 8-1 to recommend that the agency approve the new drug, from Bristol-Myers Squibb (up $0.27 to $25.15, Research) and Merck (up $0.03 to $29.22, Research). The Food and Drug Administration usually follows the advice of its panelists on applications for new drugs.

"We're encouraged by the recommendation and we look forward to discussions with the FDA," said Merck spokeswoman Tracy Ogden.

Muraglitazar, also known by its brand name Pargluva, is a dual-use pill for patients with type 2 diabetes, the most common type affecting more than 90 percent of the estimated 18.2 million diabetics in America. Less than a tenth of all cases are type 1, the more serious form of diabetes which generally affects juveniles.

The panelists also voted 7-2 in favor of using muraglitazar as a combination drug with metformin, which is used to control blood sugar levels in diabetics. However, the panelists voted 2-7 against combining the drug with sulfonylurea, which is also used to control blood sugar levels. Ogden said the panelists were apparently unsatisfied with the cardiovascular risks revealed in a muraglitazar-sulfo study.

Diabetics have difficulty producing insulin, which converts blood sugar into energy. Diabetics often suffer from high blood sugar levels, so maintaining these levels is one of the primary goals in diabetes treatment.

In addition to lowering blood sugar, muraglitazar has been shown to adjust levels of lipids, or fat in the blood, which could reduce heart disease. This is particularly important in type 2 diabetes, sometimes dubbed "diabesity" because it can be brought on by obesity, physical inactivity, aging and genetic inheritance.

Bernstein analysts project that muraglitazar will be approved and reach $1 billion in sales, but that its efficacy in reducing lipids is "too narrow" for it to effectively compete with two blockbusters that improve insulin use: Actos from Eli Lilly & Co. (up $0.41 to $56.86, Research) and Takeda, and Avandia from GlaxoSmithKline (up $0.43 to $50.50, Research).

Diabetes is seen as a promising area for the drug industry, with millions of baby boomers getting older and developing health problems that contribute to the disease. Of the 18.2 million diabetics in America, there is an estimated 5.2 million who have not been diagnosed, according to the American Diabetes Association. An additional 1.3 million are diagnosed every year, and another 41 million have "pre-diabetes," or high blood-sugar levels, and are at risk for developing type 2.

The muraglitazar vote was the third involving the FDA and diabetes-related drugs this week. On Thursday an FDA advisory panel gave the green light to Exubera, the first inhalable form of insulin, increasing its chances for regulatory approval.

The drug, if approved, could mean that millions of diabetics could throw away the needles they've used for injectable insulin. Exubera was developed by Pfizer Inc. (down $0.19 to $26.32, Research) with partners Nektar Therapeutics (up $0.66 to $19.80, Research) and Sanofi-Aventis (up $0.43 to $41.80, Research).

On Tuesday, the FDA approved Actoplus Met, a drug designed to control blood sugar level in diabetics from Takeda and Lilly.

For more on muraglitazar, click here.  Top of page

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