FDA approves DPP-4 inhibitor drug Onglyza for Type 2 diabetes
Onglyza for Type 2 diabetes

The once-daily treatment drug for Type 2 diabetes, Onglyza - generically called saxagliptin - has been approved by the US Food and Drug Administration (FDA). Onglyza has been manufactured by Bristol-Myers Squibb Co., which will also be marketing the drug, along with AstraZeneca PLC.

While Onglyza has been successfully tested in diabetics with fairly low risk of heart disease, the FDA approval of the drug necessitates that the maker Bristol-Myers Squibb conduct a post-marketing study to assess the heart safety potential of the drug in higher-risk patients.

The side-effects observed with Onglyza include headaches, infections in the upper respiratory tract and urinary tract, and skin allergies.

To be taken alongside diet and exercise, Onglyza is a DPP-4 inhibitor, designed to kindle the pancreas for making increased insulin after a meal. It will compete with Merck & Co.'s DPP-4 drug, Januvia, for Type 2 diabetes - a disease in which the body's incapability to use insulin leads to high blood-glucose levels. The DPP-4 inhibitor drugs block a particular enzyme that degrades GLP-1, which is an ephemeral hormone stimulating insulin release from the pancreas.

Commenting on the role of DPP-4 inhibitors, Mary Parks - Director of the FDA's Metabolism and Endocrinology Products' division - said: "Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the US with Type 2 diabetes."

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