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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