Otsuka announced that it has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for tolvaptan for the treatment of adult patients with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
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.
Tolvaptan is a selective V2 receptor antagonist that blocks the vasopressin-mediated activation of the cyclic AMP pathway that leads to cell proliferation and fluid secretion. It has been hypothesized that tolvaptan also inhibits cyst formation, proliferation and growth.
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