FDA Approves Once-a-Day Pill for Type 2 Diabetes

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The U.S. Food and Drug Administration on Friday approved Onglyza (saxagliptin), a new once-daily pill for use against type 2 diabetes in adults. According to an FDA statement, the medication belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which work by stimulating the pancreas to produce more insulin after mealtimes.

In type 2 diabetes, people develop a resistance to insulin or they cannot produce enough of the hormone to maintain healthy blood sugar levels.

According to the FDA, the most frequent side effects with Onglyza include infections of the upper respiratory or urinary tracts, and headache. Allergic reactions, such as rashes and hives, can also occur.

Approval came after eight clinical trials. The drug is made by Bristol-Myers Squibb and marketed by Bristol-Myers Squibb and AstraZeneca.

The application for approval came before December 2008, when the FDA began to mandate more rigorous clinical trials for new drugs, looking specifically at their effects on the cardiovascular system. However, the FDA says it will require a postmarketing study of Onglyza to track any such effects on patients.