Setback for Otsuka's tolvaptan

The US subsidiary of Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application for tolvaptan for the treatment of adult patients with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

The FDA issues CRLs to convey that its initial review of an application is complete; however, it cannot approve the application in its present form and request additional information. In its letter to Otsuka, the FDA requested Otsuka provide additional data to further evaluate the efficacy and safety of tolvaptan in patients with ADPKD.

Decision follows negative advisory panel vote