×
ADVERTISEMENT

JANUARY 22, 2019

FDA Advisory Committee Split Over Approval for Zynquista

By Marie Rosenthal

In an 8-to-8 vote, an FDA advisory committee was divided about whether the overall benefits of sotagliflozin (Zynquista, Sanofi/Lexicon) to treat adults with type 1 diabetes outweighed the risk for developing diabetic ketoacidosis (DKA).

Sotagliflozin is an investigational oral dual inhibitor of two proteins, sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2), whose function is to regulate glucose. SGLT1 is responsible for glucose absorption in the