Once again the FDA has shown that when it comes to new therapies for diabetes, particularly Type 1 diabetes, the agency believes in an abundance (perhaps an overabundance) of caution. To that point, Sanofi (SNY) and Lexicon (LXRX) announced on Friday March 22 that the FDA rejected the drug application for Zynquista, Lexicon’s SGLT-1/2 inhibitor for Type 1 diabetes.
Given the 50/50 split on the AdComm vote and that aforementioned precautionary principle that has long dominated the agency’s approach to diabetes, I had estimated the odds of approval at only slightly