FDA Panel Votes Against Lexicon's Zynquista for Type 1 Diabetes

Lexicon Pharmaceuticals recently shared the results of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting regarding their New Drug Application for Zynquista. Zynquista is an oral SGLT1/SGLT2 inhibitor intended to be used alongside insulin therapy to manage glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The Advisory Committee voted 11 to 3 against the benefits of Zynquista outweighing the risks for adults with specific conditions of T1D and CKD. These conditions include an estimated glomerular filtration rate (eGFR) between 45 and 60 mL/min/1.73 m2, or an eGFR over 60 mL/min/1.73 m2 with a urine albumin-to-creatinine ratio (uACR) greater than 30mg/g.

Despite the vote, some committee members indicated potential benefits of sotagliflozin, the active ingredient in Zynquista, for alternative sub-populations of T1D and CKD patients. Dr. Mike Exton, CEO of Lexicon Pharmaceuticals, expressed disappointment in the vote outcome but noted the supportive discussions within the diabetes community. Dr. Exton emphasized the need for an FDA-approved treatment and education on managing risks, expressing hope for collaboration with the FDA as they finalize their review. The FDA's decision will consider the Advisory Committee's vote, although it is not binding. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 20, 2024, for their final decision.