New Diabetes Drug Faces Delay, FDA Extends Review Period

The Food and Drug Administration has delayed making a decision on whether to approve a new Type 2 diabetes drug proposed by Bristol Myers-Squibb Co. and AstraZeneca PLC.

The drug, saxagliptin, would be sold under the brand name Onglyza. Concerns about possible cardiovascular side effects of the drug prompted the FDA to delay its decision until July 2009. The agency had previously said it would decide Onglyza’s fate by next week.

Onglyza belongs to a family of drugs called DPP-4 inhibitors, which increase the level of incretin hormones in the body and help lower blood-glucose levels. Januvia, a Merck & Co. drug, is the only DPP-4 drug currently on the U.S. market. Onglyza would compete with Januvia in the blockbuster diabetes drug market.

FDA Panel Favors Approval

About 23 million people in the United States have Type 2 diabetes, which causes high blood-glucose levels due to the body’s inability to use insulin. The disease can lead to increased risks of cardiovascular failure, kidney disease, and other health problems.

A panel of medical experts that advise the FDA on new drug proposals recently said clinical studies submitted showed the drug did not increase the risks of cardiovascular problems. Many drug-watchers took that vote of confidence as a recommendation that Onglyza be FDA approved. In most cases, the FDA follows the recommendations of its advisory panels, although the agency is not required to do so.

Avandia: The Sequel?

Another Type 2 diabetes drug, Avandia, led to widespread cardiovascular complications in patients. Some studies found that people taking Avandia were 30 percent to 40 percent more likely to suffer a heart attack, stroke, or other side events compared to people taking other diabetes drugs.

Last year, the FDA issued new guidelines for drug companies and required stricter clinical trials of Type 2 diabetes drugs in an effort to reduce risks of heart attack and stroke.

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