New Class of Diabetes Drugs Questioned

The FDA failed to approve the new diabetes drug dapagliflozin, from Bristol-Myers Squibb and AstraZeneca, due to several concerns that may stop the development of a whole class of drugs for Diabetes.

When the FDA rejected dapagliflozin, it also imperilled projects with SGLT2-inhibitors under development at Bristol Meyers and Johnson and Johnson. There was concern raised by the FDA panel about the mechanism of action in the kidney and urinary tract, as well as numerous smaller issues with side effects.

Previously dapagliflozin had been seen as promising because it did not appear to have negative heart/cardiovascular problems. These questions raised by the FDA likely would make research too expensive now to bring most of these drugs to market.

There have been a dearth of new diabetes drugs approved, the most recent dating back to Merck’s 2006 entry Januvia. Of course there is still a great deal of research going on into new drugs and devices, but nothing in the pileline is looming.

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Published in: on July 21, 2011 at 8:42 am  Comments (1)  
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One CommentLeave a comment

  1. Rejecting dapagliflozin was not good idea.


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