FDA weighs risks of new treatment for type 1 diabetes
Decision expected on use of SGLT1/SGLT2 inhibitors in combination with insulin therapy.
Achieving Hba1c targets for people with type 1 diabetes (T1D) can be challenging due to the sole reliance on injectable insulins, but a new day may be dawning. While the FDA weighs the risks of a new oral treatment for adults with type 1 diabetes in combination with insulin therapy, the type 1 diabetes community continues to advocate for a positive outcome. In question is the safety of the drug and questions remain. Approval is split down the middle.
In January 2019, the FDA advisory panel voted ‘eight to eight’ on the overall benefits of the drug in question. The SGLT2/SGLT2 inhibitor Zynquista™ (sotagliflozin), outweighed the risks to support approval. Developed by Lexicon Pharmaceuticals and France’s Sanofi, the FDA will consider the advisory panel’s vote when they make a final decision on March 22, 2019.