5 years after initial FDA rejection, Lexicon prepares to resubmit Type 1 diabetes hopeful Zynquista

12 Mar 2024
www.fiercepharma.com
Drug ApprovalPhase 3
Lexicon Pharmaceuticals' original Zynquista FDA rejection was in 2019. Since then, the company has persisted in its regulatory efforts.
Lexicon PharmaceuticalsA rejection five years ago, Lexicon Pharmaceuticals hasn’t given up hope on its Type 1 diabetes prospect sotagliflozin. Now, the company’s approval dreams could be coming into focus as the drugmaker prepares to refile its application.
After hearing recent FDAulatory feedback from the aLexicon Pharmaceuticalsplans to submit the drug by tType 1 diabetese year, thsotagliflozind in a press release.
“We have remained steadfast in our support of sotaglifloziLexiconpe 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” CEO Lonnel Coats noted in the release.
Lexicon is hoping for an approval that clears sotagliflozine ustype 1 diabetes to insulin therapy for adults with Type 1 diabetes mellitus and chronic kidney disease, the company said in its fourth-quarter and full-year earnings presentation (PDF). If approved, the drug will be branded as Zynquista.
Lexicon hit the first bump on its regulatory road in 2019, when the FDA rejected its bid with a safety-related comType 1 diabetes mellitusllowichronic kidney diseaseadvisory committee.Zynquista
Lexicontime, Sanofi was partnered on the drug, but the French pharmaFDAmped ship after the rejection and subsequent trial flops in Type 2 diabetes.
In the rejectSanofihe FDA cited concerns about the risk of diabetic ketoacidosis for patients taking insulin plus Zynquista. HoweveType 2 diabetestains that the risk can be managed and may be outweighed by patients' unmet needs.
Despite the FDA rejectFDA, Zynquista was approved in Europediabetic ketoacidosis a trove of phase 3 data proving ZZynquistas worth in Lexicons with chronic kidney disease when paired with insulin, the company has said.
The long-awaFDAd nod would Zynquista beneficial to Lexicon, which tooLexicon$1.2 million in total 2023 revenues. Zynquistas for the yediabetesout tochronic kidney diseasee point, some analysts had blockbuster-level expectations for the drug.
Meanwhile, the drugmaker has been able to take sotaLexiconn into another indication. The med scored approval for heart failure last year—branded as Inpefa—and launched weeks later, marking the first SGLT1/SGLT2 inhibitor to hit the U.S. market. The company is also testing the drug in hypertrophic cardiomyopathy.
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