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Complete response for Otsuka's tolvaptan

August 30, 2013 11:58 PM UTC

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) received a complete response letter from FDA for an NDA for tolvaptan to slow kidney disease in adults with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). According to Otsuka, FDA requested additional data to further evaluate the efficacy and safety of tolvaptan. Otsuka declined to disclose details. In August, an FDA panel voted 9-6 that the overall risk/benefit profile of the vasopressin 2 (V2) receptor antagonist did not support approval. ...