Possible Treatment for PKD on “Fast Track”

The Food and Drug Administration has granted “Fast Track” designation for Tolvaptan, a potential treatment for the dominant form of PKD.

Fast track programs through the FDA are designed to speed up the development and review of new drugs with exciting potential to treat serious or life-threatening conditions.

Tolvaptan is being evaluated as a way to stop or slow cyst growth in PKD patients. It may also help alleviate complications of PKD, including increased renal size, hypertension, proteinuria and renal pain.

Phase II studies for Tolvaptan are complete, and global Phase III clinical trials are expected to begin soon. The PKD Foundation supported basic research leading to the clinical trial of this drug.

For more information about Tolvaptan, contact Otsuka Maryland Research Institute, Inc., at 1-866-712-5837 or http://www.otsuka.com/.