Dapagliflozin – FDA says “Not so fast, my friend”

In the least surprising FDA news in some time, dapagliflozin has been sent packing,   Metabolic Markets has been watching and commenting on various efforts to pump up dapa’s chances which you have read about in this space, including the Cleveland Clinic’s listing of dapa on its “Top 10 innovations for 2012.”  As we commented when that story first broke, the curious bullishness of Dr Nissen who said about dapa, ““My guess is that within the next year, this will get over the goal line. This is as good as anything we’ve seen.”

As “good as anything we’ve seen.”  Except for a 9-6 panel vote against and unexplained safety signals.  A cursory PubMed search for dapa data outlines a good, but distinctly not great oral agent, in Metabolic Markets opinion.  Modest A1c and good weight loss, but not earth-shaking. Edward Chao has a very good (and free) summary of the SGLT-2 class and data if you really want to know more than you will ever need.

So is this a death knell for the class?  There are several others in mid-stage development, with J&J’s canagliflozin the next one up.  As we have learned over the years, intra-class variation is not uncommon, but will this mean the FDA will require additional data for any of those in the class?

Until then, BMS/AZ seem to be saying they will have the data soon to address the FDA.  Watching what happens in Europe will be quite telling.  Do they “withdraw” their application, which is the polite European way of saying “you don’t have a chance.”


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