July 31, 2009

Onglyza Sanctioned for Type 2 Diabetes

FRIDAY, July 31 (HealthDay News) -- Onglyza (saxagliptin) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes in adults, the agency said Friday.

The once-daily pill is meant to be combined with proper diet and exercise to help control blood sugar, the agency said in a news release. It's among a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which are designed to have the pancreas produce more insulin after a person eats. Insulin helps the body maintain normal blood sugar levels.

Onglyza was approved based on results from eight clinical studies. Makers Bristol-Myers Squibb and AstraZeneca submitted their approval application before December 2008, when the FDA imposed new clinical-study standards designed to evaluate the cardiovascular effects of diabetes drugs. While there's no evidence of increased risk of cardiovascular problems among Onglyza users, the agency said it ordered a post-market study of the drug that will concentrate on cardiovascular safety among high-risk users.

The most common reported side effects from Onglyza include upper respiratory infection, urinary tract infection, headache and allergic reactions, the FDA said.

More information

To learn more about this approval, visit the FDA.

-- Scott Roberts

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