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54.FDA Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes

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20, 2025 FDA designations: Breakthrough Therapy, Priority Review Financial forecast (reported in millions) tividenofusp alfa IV Manufacturer: Denali Proposed indications Clinical overview Mechanism of action Tividenofusp alfa is a next-generation enzyme replacement therapy (ERT) that contains the recombinant iduronate 2-sulfatase (I2S) enzyme, which breaks down heparan sulfate (HS) and dermatan sulfate in the lysosome to maintain cellular homeostasis