Posted by Michael Wonder on 05 Sep 2019
Is the FDA out to get this $2.9 billion diabetes drug class?
6 September 2019 - In March, the FDA issued a complete response letter -- the agency's euphemism for a rejection letter -- to Sanofi and Lexicon Pharmaceuticals for their application to approve Zynquista as a treatment for type 1 diabetes.
A few months later, AstraZeneca got the same notice for using Farxiga as a treatment for type 1 diabetes.
Zynquista and Farxiga are both sodium-glucose co-transporter (SGLT) inhibitors. As the name implies, SGLT proteins -- there are two main ones, SGLT-1 and SGLT-2 -- transport sodium and glucose from the kidneys back into the bloodstream. By inhibiting the proteins, more sugar ends up being excreted in the patient's urine instead of causing damage circulating through the bloodstream.
The class has been approved to treat type 2 diabetes for years, racking up substantial sales.
