Zynquista filed with FDA for Type 2 diabetes plus heart failure risk.- Lexicon Pharmaceuticals
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
The NDA submission is supported by the results from the Phase III SOLOIST clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.
Both SOLOIST and SCORED achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles.
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Lexicon Pharmaceuticals announced that it has submitted a New Drug Application to the FDA seeking approval for the marketing and sale of Zynquista (sotagliflozin) to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction.
Adults with type 2 diabetes with increased cardiovascular (CV) risk experienced superior A1C and body weight reductions from baseline across all three doses of tirzepatide compared to titrated insulin glargine in detailed results from Eli Lilly and Company's SURPASS-4 clinical trial, which were published in The Lancet.
Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes who have increased cardiovascular (CV) risk compared to titrated insulin glargine in topline results from Eli Lilly and Company's SURPASS-4 clinical trial.