Lexicon Pharmaceuticals is undergoing a significant restructuring, including laying off 60% of its workforce and eliminating its commercial operations, after receiving a letter from the Food and Drug Administration (FDA) citing “deficiencies” in its approval application for Zynquista (sotagliflozin), a diabetes drug. The company aims to save $100 million in operating costs through this move, shifting its focus to its research pipeline.
The FDA's concerns arose during the review of sotagliflozin for a specific group of people with Type 1 diabetes and chronic kidney disease, with an advisory committee already suggesting that the drug's benefits did not outweigh its risks in late October. The agency indicated that the application's shortcomings prevented discussions about potential labeling or post-marketing requirements.
Facing these regulatory hurdles, Lexicon has decided to discontinue promotion of Inpefa, another drug containing sotagliflozin used to reduce cardiovascular complications in patients with heart failure or Type 2 diabetes, chronic kidney disease, and other risk factors. While Lexicon will continue to manufacture and make Inpefa available, the company is transitioning to a “clinical development-focused” model.
Pipeline Focus
Lexicon will now prioritize its research pipeline, which includes a drug in Phase 2 testing for diabetic peripheral neuropathic pain and a preclinical obesity therapy. The company is also continuing a Phase 3 study of sotagliflozin in people with hypertrophic cardiomyopathy, exploring its potential in other therapeutic areas.
This restructuring builds upon an earlier cost-cutting initiative that involved layoffs for 75 employees, further streamlining the company's operations. The strategic shift reflects the challenges Lexicon faces in the diabetes market and its renewed commitment to advancing its clinical programs.
