FDA digs in its heels with another rejection for Lexicon's diabetes prospect Zynquista | Fierce Pharma
https://www.fiercepharma.com/pharma...lexicons-diabetes-prospect-company-scraps-all
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.
https://www.fiercepharma.com/pharma...lexicons-diabetes-prospect-company-scraps-all
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.