Dive Brief:
- Lexicon Pharmaceuticals will lay off 60% of its workforce and eliminate its commercial organization in a restructuring meant to save $100 million in operating costs next year.
- The shakeup follows Lexicon’s receipt of a letter from the Food and Drug Administration that cited “deficiencies” in the company’s approval application for its diabetes drug Zynquista. The therapy has been under review by the agency, which was aiming to reach a decision by Dec. 20.
- Lexicon will now pivot to focus on 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 testing sotagliflozin, the active ingredient of Zynquista, in a Phase 3 study of people with hypertrophic cardiomyopathy.
Dive Insight:
Lexicon’s latest bid to win approval of sotagliflozin in people with diabetes already was in trouble. The company, which in 2019 tried and failed to secure a clearance in Type 1 diabetes broadly, had focused its most recent application on a narrower group of people with Type 1 diabetes and chronic kidney disease.
The FDA agreed to review sotagliflozin for this use but, in late October, a group of experts the agency convened to aid it determined the drug’s benefits did not outweigh its risks. While the FDA doesn’t have to follow the advice of its advisory committees, it usually does, seemingly dimming Lexicon’s chances of winning approval by Dec. 20.
The agency hasn’t gotten there yet, indicating to Lexicon that shortcomings in the drug application prevent it from discussing a potential label or post-marketing requirements.
Facing an uphill battle, Lexicon has decided to retrench, eliminating the sales team it had built up in anticipation of winning approval of Zynquista. The company will also halt promotion of its drug Inpefa, which also contains sotagliflozin but is used to reduce the likelihood of 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 available Inpefa, it is otherwise transitioning to become a “clinical development-focused” company. The $100 million in anticipated savings is in addition to an earlier $40 million cut to operating costs that involved layoffs for 75 employees.
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- Source: https://www.biopharmadive.com/news/lexicon-layoffs-restructuring-zynquista-deficiencies-fda/733712/