(Reuters) -Lexicon Pharmaceuticals said on Monday the U.S. Food and Drug Administration requires more time to review the company’s previously submitted additional data on its experimental drug, zynquista, for patients with type 1 diabetes. The health regulator now expects to provide feedback in the fourth quarter, delaying its initial timeline set for the end of […]
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Lexicon expects delay in FDA feedback on additional data for its diabetes drug
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(Reuters) -Lexicon Pharmaceuticals said on Monday the U.S. Food and Drug Administration requires more time to review the company’s previously submitted additional data on its experimental drug, zynquista, for patients with type 1 diabetes.
The health regulator now expects to provide feedback in the fourth quarter, delaying its initial timeline set for the end of September.
Lexicon’s submission followed a complete response letter from the FDA issued in December 2024, which raised concerns about zynquista’s increased risk of diabetic ketoacidosis, a serious complication of diabetes.
The new data aims to address these safety concerns and bolster the add-on drug’s benefit-risk profile for type 1 diabetes.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Mohammed Safi Shamsi)