REJECTED: FDA demands more data for Otsuka kidney drug tolvaptan
This article was originally published in Scrip
Executive Summary
After an FDA panel of advisers earlier this month expressed concerns over liver injury with Otsuka's tolvaptan and urged against the experimental medicine's approval as a therapy to slow kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), the firm's late evening 29 August revelation the agency denied the company's new drug application (NDA) came as little surprise.