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Lexicon Seeks Approval Of Sotagliflozin For Use In Type 2 Diabetes Patients With Heart Failure

Lexicon Pharmaceuticals Inc. (LXRX) has submitted a New Drug Application to the FDA seeking approval of Sotagliflozin for the treatment of heart failure in adults with type 2 diabetes.

The submission of the New Drug Application is based on results from phase III trials of Sotagliflozin, dubbed SOLOIST and SCORED.

The SOLOIST trial involved patients with type 2 diabetes who had recently been hospitalized for worsening heart failure while the SCORED clinical study involved patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.

Within 60 days, the FDA will determine whether the New Drug Application is complete and acceptable for filing, following which the company will be notified of the decision date.

Sotagliflozin received approval in the EU in 2019 as an adjunct to insulin for certain overweight adults with type 1 diabetes, and is marketed there under the brand name Zynquista. However, the same year, the FDA had denied approval for it for use in type 1 diabetes.

LXRX has traded in a range of $3.26 to $9.65 in the last 1 year. The stock closed Thursday's trading at $4.17, up 1.71%.

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