A New Type 2 Med
Saxagliptin (Onglyza), a new type 2 medication, has received Food and Drug Administration (FDA) approval and should be available soon by prescription.
Like sitagliptin (Januvia), saxagliptin is a DPP-4 inhibitor that helps control blood glucose levels by blocking an enzyme that deactivates glucose-lowering hormones called incretins. These hormones spur the pancreas to produce insulin after a meal.
Saxagliptin is taken once daily as a tablet, with or without food, and can be used alone or in combination with other diabetes drugs.
The medication was submitted to the FDA for approval before December 2008, when the agency began to require a more rigorous review of cardiovascular safety for new diabetes drugs. Based on an analysis of the eight studies submitted, an FDA panel voted in April that saxagliptin did not pose a threat to patients at low risk for a heart attack or stroke, paving the way for its approval. However, the FDA is requiring a post-market study to ensure that saxagliptin doesn't increase cardiovascular risks in older and sicker people.
Bristol-Myers Squibb and AstraZeneca, which will jointly market saxagliptin, say that the new medication will be priced on a par with sitagliptin. Merck sold over $400 million worth of sitagliptin in the first three months of this year.