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Panel Nixes Tolvaptan On Weak Efficacy Data And Liver Risks

 
• By Sarah Karlin-Smith

Small, unclear drug effect and hepatotoxicity take down Otsuka’s tolvaptan kidney disease indication at Cardiovascular and Renal Drugs Advisory Committee review.

FDA advisors voted 9-6 against approval of Otsuka Pharmaceutical Co. Ltd.’s tolvaptan to slow kidney disease citing the sponsor’s failure to demonstrate a robust drug effect, a flaw that could not be overlooked when balanced with tolvaptan’s high risk of drug-induced liver injury.

“I felt the benefit was real but very small, the risk was real but large and in balance I felt...

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