FDA Panel To Review Two Proposed Diabetes Drugs Related...

FDA Panel To Review Two Proposed Diabetes Drugs Related to Heart Attacks and Strokes

FDA Panel To Review Two Proposed Diabetes Drugs Related to Heart Attacks and Strokes
March 09, 2009
-By Jennifer Corbett Dooren,
Dow Jones Newswires; 202-862-9294

WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration panel will review two proposed drugs to treat Type 2 diabetes next month.

According to a meeting notice posted on the FDA's Web site Monday, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee will discuss Bristol-Myers Squibb Co.'s (BMY) saxagliptin tablets on April 1 and Novo Nordisk Inc.'s (NVO) liraglutide injection on April 2.

Saxagliptin, which is similar to Merck & Co.'s (MRK) diabetes drug Januvia, is also being developed with AstraZeneca Inc. (AZN).

The agency is expected to look closely at both treatments to see if they boost the risks of heart attacks and strokes. The drugs are designed to lower blood glucose or blood-sugar levels in people with diabetes.

In December the FDA issued a new guidance document that recommended more stringent clinical trials for diabetes drugs to better assess heart-attack and stroke risks. In a change that was effective immediately, the agency said studies should "demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies."

FDA guidance documents aren't binding, but the agency can refuse to approve drugs that don't meet the recommendations. Applications for saxagliptin and liraglutide were submitted to the FDA before the new guidelines on diabetes clinical studies were released so it's unclear whether the FDA will require more data to be submitted for the drugs.

The FDA recommended diabetes clinical studies include older and sicker patients at higher risk of having a heart attack or stroke and that they be followed for as many as two years rather than three to six months.

Saxagliptin falls into a class of drugs known DPP-4 inhibitors. DPP-4 inhibitors work by increasing the level of so-called incretin hormones in the body that help lower blood-glucose levels. So far the only DPP-4 drug on the U.S. market is Merck's Januvia.

Liraglutide is a long-acting form of a hormone known as GLP-1 that triggers the release of insulin in the body, which is needed to properly digest and use sugar from food. That drug falls into a class of drugs known as incretin mimetics and is similar to Byetta, by Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY), which is injected twice daily. Liraglutide is designed to be injected once daily.

About 23 million Americans have Type 2 diabetes, a disease characterized by high blood-glucose levels that result from the body's inability to use insulin. Type 2 diabetes is linked with obesity, poor diet and lack of exercise. Diabetes also increases the risk of heart attacks and strokes, as well as kidney and other health problems.

(END) Dow Jones Newswires
03-09-09 1507ET
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