Lexicon Pharmaceuticals faced a setback as a Food and Drug Administration (FDA) advisory committee voted against the approval of Zynquista (sotagliflozin) for use as an adjunct to insulin therapy in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The panel's decision, with 11 votes against and 3 in favor, casts doubt on the drug's potential approval for this specific indication.
The primary concern raised during the meeting revolved around whether the data in the revised application supported a favorable benefit-risk assessment. The FDA previously rejected Zynquista in 2019 due to concerns that the risk of diabetic ketoacidosis (DKA) outweighed the benefits for the proposed patient population.
Company Response and Future Outlook
Lexicon Pharmaceuticals expressed disappointment with the committee's decision but highlighted the supportive discussions and the recognized need for sotagliflozin within the diabetes community. The company emphasized the urgency for an FDA-approved treatment option, coupled with clear education on managing associated risks, particularly DKA.
According to an FDA briefing document, the initial rejection of Zynquista stemmed from the agency's determination that the risk of DKA was too significant relative to the anticipated benefits in the intended patient group. The recent panel vote considered a revised indication aimed at limiting the population to individuals with both T1D and CKD.
Sotagliflozin's Broader Applications
While this decision impacts the T1D and CKD indication, sotagliflozin received FDA approval last year under the name Inpefa for the treatment of heart failure. Furthermore, Viatris holds an exclusive license to commercialize sotagliflozin outside the U.S. and Europe for all indications. Lexicon had previously announced a Prescription Drug User Fee Act (PDUFA) goal date of December 20 and was preparing for an early 2025 launch, prior to the panel's vote.
Lexicon Pharmaceuticals had expressed confidence in the benefit/risk profile of sotagliflozin for adults with type 1 diabetes and CKD. A recent analysis of Phase 3 data also suggested protective effects of sotagliflozin in patients with diabetic kidney disease.
