New Diabetes Pill – Type Of Diabetes Pill “Likely Dead”, says the leading scientist!
Is this the new Diabetes pill???
This is the statement by the leading scientist in charge of the project:
In a surprisingly broad and lengthy discussion of where the data fell short, the FDA panelists cited concerns on not only the drug’s safety but also efficacy.
As expected, panelists were concerned over the potential breast/bladder cancer risk, particularly the 5X increase and the inability to explain the imbalance.
Concerns were also expressed over which patient population should take the drug (insufficient data on patients with CHF, proteinuria, renally or liver impaired, or over 65 years old), and how to use the drug (insufficient drug-drug interaction data).
More, panelists were widely varying on not only WHAT needed to be addressed but also HOW it should be addressed.
Many expressed discomfort in prescribing the drug to such a large community without a large-scale outcomes study designed with these questions in mind.
Others suggested that such a study or studies would require such a large scale (could be 30-100k) that would be infeasible and discourage development of novel drugs.
Dapagliflozin was a diabetes drug where the safety on heart risk, which felled GlaxoSmithKline’s Avandia, actually looked good.
But there were too many other things wrong. Still, the market for diabetes pills is pretty big. The last really successful mass market launch was of Merck’s diabetes pill, Januvia, in 2006.
Erik Gordon, a professor at the University of Michigan’s business school, wrote in an email that “The panel did its job. There were questions about serious complications that [Bristol-Myers] tried to finesse.”
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