U.S. Food and Drug Administration Approves Saxagliptin (Onglyza) for Type 2 Diabetes

CB107673Yesterday, July 31, 2009, the FDA approved use of saxagliptin, a DPP4 inhibitor, in adults with type 2 diabetes as an adjunct to diet and exercise.  Bristol-Myers Squibb and AstraZeneca will sell the drug under the brand name Onglyza.

The drug’s only competitor in the U.S. market is Merck’s Januvia, which sold over $400 million in the first quarter of this year.

“How does saxagliptin work?”

Incretin hormones influence secretion of insulin and glucagon by the pancreas.  The dipeptidyl peptidase-4 (DPP4) enzyme inactivates these incretin hormones.  Saxagliptin inhibits the DPP4 enzyme, resulting in increased insulin production and decreased production of glucagon. 

“But it causes bad side effects, right?”

No, not that we know of yet.  Overall, incidence of side effects is similar to placebo side effects.  The drug may slightly increase headache, runny nose, and sore throat.  Risk of hypoglycemia is increased minimally, if at all. 

“Can I use Onglyza with my other diabetes drugs?”

It’s FDA-approved for use by itself or in combination with metformin, sulfonylureas, and thiazolidinediones. 

“What’s the dose?”

2.5 or 5 mg by mouth daily, without regard to meals. 

“Is this a tremendous breakthrough in treatment of type 2 diabetes?”

Probably not.  But it’s good to have another treatment option.  And competition among the drug manufacturers tends to bring down prices.   

Steve Parker, M.D.


Bristol-Myers Squibb.   Press Release from Bristol-Myers Squibb, July 31, 2009.

Goldstein, Jacob.  Saxagliptin approval: Finally, competition for Merck’s Januvia.  WSJ.com Health Blog, July 31, 2009.

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