On Friday afternoon the FDA finally gave the green light to Type 2 diabetes drug Onglyza (saxagliptin), marking AstraZeneca's first new drug approval in six year. Bristol-Myers Squibb is also partnered on the drug.
Onglyza is part of a class of drugs known as DPP-4 inhibitors, which stimulate the pancreas to make more insulin after eating a meal. It will compete with Merck's Januvia, the only other DPP-4 on the market. Januvia raked in $1.4 billion in sales last year.
AstraZeneca and BMS submitted their application for Onglyza before December 2008, when the FDA put new standards in place for testing the cardiovascular risks of experimental diabetes drugs. The agency notes that although Onglyza is not associated with increased heart risks, it's still asking the two developers to conduct a postmarket study examining the cardiovascular side effects of the drug in a higher risk population.
- check out the FDA announcement
- here's the release