Lexicon Pharmaceuticals has already thrown in the towel on its commercial efforts after a years-long uphill battle to get its insulin adjunct prospect Zynquista (sotagliflozin) across the FDA finish line. Now, after a November advisory committee vote that didn’t fall in Lexicon’s favor, the agency made it official with a complete response letter.
The rejection came as no surprise to Lexicon and aligns with its previously communicated response to the agency's disapproval.
After receiving a notice of deficiencies in its Zynquista application from the FDA last month, the company made the choice to cut its entire commercial sales team, effectively shifting back into a clinical-stage biotech. Lexicon will continue to manufacture and provide to patients its Inpefa, a heart failure version of sotagliflozin that won approval in 2023, albeit with no further promotional efforts.
By December 31, the drugmaker will slash its workforce by 60% as part of the plan, which should cut full-year operating costs by $100 million. The latest move follows an August effort to save $40 million annually by cutting 50% of its field force.
“Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline, including our near-term focus on LX9211 for diabetic neuropathic pain (DPNP) with top-line data from our PROGRESS Phase 2b study anticipated in Q1 2025, and pursuing innovations that we believe can profoundly benefit patients.," Lexicon CEO Mike Exton, Ph.D., said in a recent company release.
The company is also studying Inpefa in hypertrophic cardiomyopathy and a non-incretin oral prospect for obesity and other cardiometabolic disorders. Inpefa, a dual SGLT1/2 inhibitor and Lexicon’s sole commercial product, brought in $1.7 million in third-quarter sales.
Lexicon’s most recent efforts to bring Zynquista to patients with Type 1 diabetes and chronic kidney disease came five years after the FDA’s initial rejection. The drug faced an advisory committee back then as well, ending in an 8-8 vote and resulting in a safety-related complete response letter. The troubles left former partner Sanofi to jump ship in a debacle that cost the French pharma $260 million to exit after Lexicon claimed breach of contract.
The more recent advisory committee vote in November came out to 11-3, with most panelists agreeing that the benefits of the drug do not outweigh the risks, namely that of diabetic ketoacidosis.