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DATA GRAPHICS | Data Byte

Seven PDUFA dates on FDA’s January agenda

Decisions include Ozempic for CKD, a non-opioid painkiller, AZ-Daiichi’s TROP2 ADC, and an allogeneic T cell therapy

January 8, 2025 1:54 AM UTC

The already strong growth of semaglutide may get another boost with Novo Nordisk expecting a decision this month on use of Ozempic to treat chronic kidney disease in Type II diabetes patients. 

Last year brought clinical readouts demonstrating the GLP-1 drug class may be useful for a variety of conditions beyond obesity and diabetes, including heart failure, MASH, sleep apnea and chronic kidney disease. Last month, sleep apnea data from competitor Eli Lilly and Co. (NYSE:LLY) led to FDA approval of Zepbound tirzepatide in the indication. Now, Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) hopes to add CKD to Ozempic’s label...

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