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.
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To learn more about this approval, visit the FDA.
— Scott Roberts
Last Updated: July 31, 2009
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