FDA Panel Rejects Lexicon's Zynquista For Type 1 Diabetes

On Thursday, Lexicon Pharmaceuticals Inc. LXRX announced the outcome of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin).

The company is seeking approval for the oral SGLT1/SGLT2 inhibitor as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).

The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks, as having an estimated glomerular filtration rate (eGFR) >45 to <60 mL/min.1.73 m2 or eGFR >60 mL/min/1.73 m2 and urine albumin-to-creatinine ratio (uACR) > 30mg/g. 

As part of the discussion, certain committee members expressed support for sotagliflozin in alternative sub-populations of people with T1D and CKD, where they believed the benefits potentially outweigh the risks.

As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 20.

The FDA approved Sotagliflozin, branded as Inpefa, in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

In 2019, the FDA issued a complete response letter (CRL) regarding the NDA for sotagliflozin for type 1 diabetes. Despite FDA rejection, the European Medicines Agency approved the drug in April 2019, covering TID patients who could not achieve adequate glycemic control despite optimal insulin therapy.

In 2021, at Lexicon's request, the FDA issued a public Notice of Opportunity for Hearing (NOOH) on whether there were grounds for denying such approval.

Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance to discuss a path forward for resubmission and potential approval of the NDA.

Lexicon Pharmaceuticals resubmitted its NDA for sotagliflozin in June. The company anticipated a six-month review and a potential launch in early 2025.

Also, in 2019, after four years of collaboration, Sanofi SA SNY terminated the sotagliflozin-related agreement and paid Lexicon Pharmaceuticals $260 million.

Two weeks ago, Viatris Inc. VTRS obtained an exclusive license from Lexicon to commercialize sotagliflozin in all indications outside of the U.S. and Europe. Lexicon retains sole commercialization rights for sotagliflozin in all indications in the U.S. and Europe.

Price Action: LXRX stock is down 38.46% at $1.22 during the premarket session at last check Friday.

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